FDA 510(k) Applications for Medical Device Product Code "DQO"
(Catheter, Intravascular, Diagnostic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K024126 | ABBOTT LABORATORIES | CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT | 01/14/2003 |
| K011217 | ABBOTT LABORATORIES | CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT | 05/16/2001 |
| K230411 | Abbott Medical | Dragonfly OpStarÖ Imaging Catheter | 04/14/2023 |
| K192019 | Abbott Medical | Dragonfly OpStarÖ Imaging Catheter, AptiVueÖ Software version E.5.1 | 11/08/2019 |
| K192267 | Abbott Medical | ILUMIEN System with AptiVue Software version D.3 | 12/17/2019 |
| K231293 | Accurate Medical Therapeutics | DrakonÖ and Sequre« Microcatheters | 06/01/2023 |
| K203487 | Accurate Medical Therapeutics Ltd | Drakon and Sequre Microcatheters | 12/11/2020 |
| K202797 | Accurate Medical Therapeutics Ltd. | Drakon and Sequre Microcatheters | 10/23/2020 |
| K173430 | Accurate Medical Therapeutics Ltd. | SeQure« NF and SeQure« Microcatheters | 01/26/2018 |
| K021015 | ACIST MEDICAL SYSTEMS | ACIST PLUS 4 ANGIOGRAPHIC CATHETER | 04/26/2002 |
| K012983 | ACIST MEDICAL SYSTEMS, INC. | ACIST 4 FRENCH ANGIOGRAPHIC CATHETER | 03/13/2002 |
| K992631 | ACUSON CORP. | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER | 12/15/1999 |
| K955111 | ADAM SPENCE CORP. | MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER | 01/31/1996 |
| K964331 | ADAM SPENCER CORP. | ASC HIGH PRESSURE BRAIDED TUBES | 01/13/1997 |
| K963092 | ADAM SPENCER CORP. | MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER | 01/13/1997 |
| K143604 | ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S | Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters | 06/25/2015 |
| K964033 | ANGIODYNAMICS, INC. | 3F ANGIOPTIC ANGIOGRAPHIC CATHETER | 05/06/1997 |
| K032376 | ANGIODYNAMICS, INC. | ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER | 08/26/2003 |
| K151724 | ANGIODYNAMICS, INC. | AngioDynamics Mariner Angiographic Catheters | 10/14/2015 |
| K061733 | ANGIODYNAMICS, INC. | ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER | 08/24/2006 |
| K112452 | ANGIODYNAMICS, INC. | ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS | 03/30/2012 |
| K001578 | ANGIODYNAMICS, INC. | ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER | 10/13/2000 |
| K003901 | ANGIODYNAMICS, INC. | ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER | 01/17/2001 |
| K173762 | AngioDynamics, Inc. | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters | 07/18/2018 |
| K163141 | AngioDynamics, Inc. | NAMIC ClearaCIL Contrast Injection Lines | 01/06/2017 |
| K161596 | AngioDynamics, Inc. | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters | 04/28/2017 |
| K042685 | ANGIOMETRX INC. | METRICATH SYSTEM | 11/18/2004 |
| K024000 | ANGIOMETRX INC. | METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER | 06/26/2003 |
| K984627 | ARTERIAL VASCULAR ENGINEERING, INC. | AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER | 07/27/1999 |
| K051561 | ASAHI INTECC CO., LTD. | ASAHI ANGIOGRAPHIC CATHETER | 11/02/2005 |
| K150232 | ASHITAKA FACTORY OF TERUMO CORP. | Radifocus Optitorque Angiographic Catheter | 10/19/2015 |
| K170223 | ASHITAKA FACTORY OF TERUMO CORPORATION | Progreat | 07/21/2017 |
| K955485 | B. BRAUN MEDICAL, INC. | BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS | 02/23/1996 |
| K190126 | Bend It Technologies Ltd | Bendit2.7 Steerable Microcatheter | 08/22/2019 |
| K012749 | BIOCARDIA, INC. | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 | 01/24/2002 |
| K022004 | BIOSENSORS INTERNATIONAL-USA | CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 | 03/12/2003 |
| K101669 | BIOSENSORS INTL. PTE. LTD. | THERMODILUTION CATHETER | 07/01/2010 |
| K083384 | BIOSENSORS INTL. PTE. LTD. | THERMODILUTION CATHETER | 01/05/2010 |
| K003105 | BIOSPHERE MEDICAL | BIOSPHERE MEDICAL INFUSION CATHETER | 05/22/2001 |
| K062126 | BIOSPHERE MEDICAL, INC. | EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 | 08/09/2006 |
| K102633 | BIOTEQUE CORP. | BIOTEQ ANGIOGRAPHIC CATHETER | 09/09/2011 |
| K050684 | BOSTON SCIENTIFIC CORP. | ATLANTIS PV | 05/20/2005 |
| K050577 | BOSTON SCIENTIFIC CORP. | ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 | 03/30/2005 |
| K040776 | BOSTON SCIENTIFIC CORP. | ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 | 04/29/2004 |
| K022621 | BOSTON SCIENTIFIC CORP. | BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER | 09/04/2002 |
| K050863 | BOSTON SCIENTIFIC CORP. | IMAGER II ANGIOGRAPHIC CATHETER | 09/02/2005 |
| K121694 | BOSTON SCIENTIFIC CORP. | IMAGER II ANGIOGRAPHIC CATHETER | 09/14/2012 |
| K120893 | BOSTON SCIENTIFIC CORP. | IMAGER II ANGIOGRAPHIC CATHETERS | 03/29/2012 |
| K120495 | BOSTON SCIENTIFIC CORP. | IMPULSE AND EXPO ANGIOGRAPHIC CATHETER | 05/21/2012 |
| K060175 | BOSTON SCIENTIFIC CORP. | ISIGHT IMAGING CATHETER, MODEL 38986 | 03/24/2006 |
| K971607 | BOSTON SCIENTIFIC CORP. | MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS | 07/24/1997 |
| K970207 | BOSTON SCIENTIFIC CORP. | MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS | 07/31/1997 |
| K063312 | BOSTON SCIENTIFIC CORP. | MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 | 11/30/2006 |
| K023681 | BOSTON SCIENTIFIC CORP. | RENEGADE STC 18 MICROCATHETER | 11/26/2002 |
| K152605 | BOSTON SCIENTIFIC CORPORATION | Impulse Angiographic Catheter, Expo Angiographic Catheter | 10/29/2015 |
| K000743 | BOSTON SCIENTIFIC SCIMED, INC. | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 | 09/06/2000 |
| K961499 | BOSTON SCIENTIFIC SCIMED, INC. | LAGUNA SOFTIP DIAGNOSTIC CATHETERS | 10/17/1996 |
| K000956 | BOSTON SCIENTIFIC SCIMED, INC. | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS | 04/21/2000 |
| K992123 | BOSTON SCIENTIFIC SCIMED, INC. | SCIMED IMPULSE ANGIOGRAPHIC CATHETERS | 08/23/1999 |
| K982077 | BOSTON SCIENTIFIC SCIMED, INC. | SELECTOR DIAGNOSTIC CATHETER | 08/11/1998 |
| K010707 | BOSTON SCIENTIFIC, TARGET | ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 | 03/29/2001 |
| K011664 | BOSTON SCIENTIFIC/MEDI-TECH | IMAGER II ANGIOGRAPHIC CATHETER | 09/07/2001 |
| K020012 | BOSTON SCIENTIFIC/MEDI-TECH | MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER | 01/29/2002 |
| K980575 | C.R. BARD, INC. | SITESEER ANGIOGRAPHIC CATHETER | 05/15/1998 |
| K971034 | C.R. BARD, INC. | USCI MAINSTAY GUIDING CATHETER | 05/28/1997 |
| K960056 | C.R. BARD, INC. | USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC | 10/23/1996 |
| K003020 | CD LEYCOM BV | CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER | 05/11/2001 |
| K031599 | CD LEYCOM BV | CD LEYCOM PRESSURE/VOLUME CATHETERS | 12/09/2003 |
| K071196 | COEUR, INC. | DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS | 09/06/2007 |
| K151126 | Colibri Technologies Inc. | Foresight Intracardiac Echocardiography (ICE) System | 12/18/2015 |
| K162789 | Conavi Medical Inc. | Foresight Intracardiac Echocardiology (ICE) System | 03/28/2017 |
| K003086 | CONCENTRIC MEDICAL, INC. | CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 | 05/16/2001 |
| K072796 | CONCENTRIC MEDICAL, INC. | MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 | 12/18/2007 |
| K113260 | CONCENTRIC MEDICAL, INC. | MODIFIED CONCENTIRC MICROCATHETER | 03/09/2012 |
| K111619 | CONCENTRIC MEDICAL, INC. | MODIFIED CONCENTRIC MICROCATHETER | 07/06/2011 |
| K131437 | CONCENTRIC MEDICAL, INC. | MODIFIED CONCENTRIC MICROCATHETER | 10/11/2013 |
| K091961 | CONCENTRIC MEDICAL, INC. | MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 | 07/30/2009 |
| K180792 | Cook Incorporated | Arterial Pressure Monitoring Set/Tray | 11/30/2018 |
| K180846 | Cook Incorporated | Arterial Pressure Monitoring Set/Tray | 12/19/2018 |
| K173289 | Cook Incorporated | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter | 11/15/2017 |
| K172635 | Cook Incorporated | High-Flo Silver Polyethylene Catheter | 04/03/2018 |
| K180286 | Cook Incorporated | Polyethylene Catheter | 10/26/2018 |
| K181722 | Cook Incorporated | Polyethylene Catheter | 03/22/2019 |
| K171264 | Cook Incorporated | Royal Flush Catheter | 01/25/2018 |
| K180054 | Cook Incorporated | Royal Flush Plus High-Flow Catheter | 10/05/2018 |
| K161822 | Cook Incorporated | Torcon NB Advantage Catheters | 10/27/2016 |
| K162448 | Cook Incorporated | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter | 05/26/2017 |
| K133130 | COOK, INC. | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | 01/09/2015 |
| K002254 | COOK, INC. | COOK PRESSURE MONITORING CATHETER | 03/16/2001 |
| K974774 | COOK, INC. | ENVY GUIDING CATHETER | 10/16/1998 |
| K122937 | COOK, INC. | SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) | 12/14/2012 |
| K960975 | CORDIS CORP. | 1-4F INFINITI ANGIOGRAPHIC CATHETER | 04/02/1996 |
| K962759 | CORDIS CORP. | 4F NYLEX ANGIOGRAPHIC CATHETER | 10/10/1996 |
| K971646 | CORDIS CORP. | 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER | 07/14/1997 |
| K970854 | CORDIS CORP. | 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER | 09/30/1997 |
| K992347 | CORDIS CORP. | CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS | 10/08/1999 |
| K991673 | CORDIS CORP. | CORDIS TEMPO ANGIOGRAPHY CATHETER | 05/26/1999 |
| K020316 | CORDIS CORP. | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU | 03/20/2002 |
| K973401 | CORDIS CORP. | TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS) | 11/18/1997 |
| K000579 | CORDIS CORP. | TEMPO AQUA ANGIOGRAPHIC CATHETER | 05/03/2000 |
| K212977 | Cordis Corporation | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | 02/17/2022 |
| K232573 | Cordis US Corp. | INFINITIÖ Ambi Angiographic Catheter | 11/21/2023 |
| K181836 | Cordis, a Cardinal Health Company | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters | 08/08/2018 |
| K090427 | CURATIVE MEDICAL TECHNOLOGY, INC. | URSA ANGIOGRAPHIC CATHETER | 01/29/2010 |
| K123818 | CURATIVE MEDICAL TECHNOLOGY, INC. | URSA ANGIOGRAPHIC CATHETER | 03/04/2013 |
| K982299 | DAIG CORP. | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER | 10/19/1998 |
| K962805 | DAIG CORP. | SPYGLASS ANGIOGRAPHIC CATHETER | 10/15/1996 |
| K965249 | DAIG CORP. | SPYGLASS ANGIOGRAPHIC CATHETER | 02/21/1997 |
| K971616 | DATA SCIENCES INTL., INC. | BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) | 11/04/1998 |
| K023591 | DEROYAL INDUSTRIES, INC. | ULTRA HIGH PRESSURE INJECTOR LINES | 06/18/2003 |
| K110103 | EDWARDS LIFESCIENCES LLC | EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER | 02/11/2011 |
| K014054 | EDWARDS LIFESCIENCES, LLC. | EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL | 03/08/2002 |
| K034043 | ELCAM MEDICAL A.C.A.L. | H-FLOW VALVE | 06/30/2004 |
| K232536 | Embolx, Inc. | Soldier Microcatheter | 02/23/2024 |
| K000820 | ENDOSONICS CORP. | AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 | 06/05/2000 |
| K242966 | Gentuity, LLC | Gentuity« HF-OCT Imaging System with Vis-Rx Prime« Micro-Imaging Catheter | 01/31/2025 |
| K230620 | Gentuity, LLC | Gentuity« HF-OCT Imaging System with Vis-Rx« Micro-Imaging Catheter | 08/08/2023 |
| K970469 | GUIDANT CARDIAC AND VASCULAR SURGERY | EVT ANGIOSCALE ANGIOGRAPHIC CATHETER | 05/08/1997 |
| K021283 | GUIDANT CORP. | GUIDANT BALLOON CATHETER, SEVERAL MODELS | 05/02/2002 |
| K962829 | HARMAC MEDICAL PRODUCTS, INC. | HARMAC BALLOON ANGIOGRAPHIC CATHETER | 10/16/1997 |
| K963335 | HARMAC MEDICAL PRODUCTS, INC. | HARMAC BALLOON WEDGE PRESSURE CATHETER | 10/16/1997 |
| K063784 | ICU MEDICAL, INC | DYE MANAGEMENT SYSTEM | 04/16/2007 |
| K052865 | ICU MEDICAL, INC. | HOSPIRA CATH LAB CONVENIENCE KITS | 12/22/2005 |
| K233975 | Imperative Care, Inc. | Zoom 6F Insert Catheters | 04/02/2024 |
| K052908 | Infraredx, Inc. | INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 | 06/23/2006 |
| K070011 | IRVINE BIOMEDICAL,INC.(IBI) | IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER | 03/20/2007 |
| K003938 | JOMED, INC. | TRAK BACK II | 01/18/2001 |
| K031485 | KERBEROS PROXIMAL SOLUTIONS | RINSPIRATION SYSTEM | 09/25/2003 |
| K041291 | KERBEROS PROXIMAL SOLUTIONS, INC. | RINSPIRATION SYSTEM | 05/21/2004 |
| K041123 | KERBEROS PROXIMAL SOLUTIONS, INC. | RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 | 08/26/2004 |
| K141453 | LIGHTLAB IMAGING, INC. | ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER | 09/19/2014 |
| K141769 | LIGHTLAB IMAGING, INC. | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER | 08/18/2014 |
| K952984 | MAP MEDICAL EQUIPMENT, INC. | MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) | 01/29/1996 |
| K990173 | MAXXIM MEDICAL | PATHFINDER II ANGIOGRAPHIC CATHETER | 12/21/1999 |
| K000825 | MEDI-DYNE, INC. | 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER | 09/21/2000 |
| K002416 | MEDICAL DEVICE TECHNOLOGIES, INC. | GOLDEN-RULE SCALING CATHETER | 09/11/2000 |
| K091780 | MEDIGUIDE, LTD. | GUIDED MEASUREMENT CATHETER (GMC) | 10/16/2009 |
| K965112 | MEDLINE INDUSTRIES, INC. | MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS | 10/10/1997 |
| K160660 | Medline Industries, Inc. | Medline Waste Station | 01/19/2017 |
| K120008 | MEDLINE, INDUSTRIES, INC. | MEDLINE HIGH PRESSURE INJECTION TUBING | 08/17/2012 |
| K050371 | MEDRAD, INC. | MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER | 06/07/2005 |
| K161287 | MEDTRONIC VASCULAR | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak | 08/19/2016 |
| K980973 | MEDTRONICS INTERVENTIONAL VASCULAR | MEDTRONIC ANGIOGRAPHIC CATHETER | 12/10/1998 |
| K191608 | Merit Medical Systems, Inc. | Impress Angiographic Catheter | 07/16/2019 |
| K233268 | Merit Medical Systems, Inc. | Impress Angiographic Catheter | 05/22/2024 |
| K093004 | MERIT MEDICAL SYSTEMS, INC. | IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING | 02/12/2010 |
| K053171 | MERIT MEDICAL SYSTEMS, INC. | MERIT IMPRESS DIAGNOSTIC CATHETER | 01/19/2006 |
| K110643 | MERIT MEDICAL SYSTEMS, INC. | MERIT MARQUIS FLOW SWITCH | 07/01/2011 |
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| K120917 | MICROVENTION, INC. | HEADWAY DUO MICROCATHETER | 08/02/2012 |
| K032624 | MICRUS CORP. | MICRUS MICROCATHETER | 09/10/2003 |
| K070456 | MICRUS ENDOVASCULAR CORPORATION | MICRUS COURIER ENZO MICROCATHETER 0.017 | 05/24/2007 |
| K072526 | MICRUS ENDOVASCULAR CORPORATION | MICRUS COURIER ENZO MICROCATHETER 0.0190 | 10/05/2007 |
| K060116 | MICRUS ENDOVASCULAR CORPORATION | MICRUS COURIER MICROCATHETERS | 05/12/2006 |
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| K242420 | phenox Ltd | pNOVUS 21 Microcatheter | 11/12/2024 |
| K221279 | phenox Ltd | pNOVUS 21 Microcatheter | 11/28/2022 |
| K121734 | SCIENTIA VASCULAR , LLC | PLATO MICROCATH 27 MICROCATHETER | 07/30/2012 |
| K143398 | SCIENTIA VASCULAR , LLC | Plato MICROCATH 27B Microcatheter | 06/26/2015 |
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| K101239 | ST. JUDE MEDICAL | VIEWFLEX PLUS ICE CATHETER | 06/02/2010 |
| K192122 | Stryker | Trevo Trak 21 Microcatheter | 11/22/2019 |
| K140356 | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD | SUMMED HIGH PRESSURE LINE | 03/20/2015 |
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| K180677 | Surefire Medical, Inc. | Surefire Spark Infusion System | 04/03/2018 |
| K193647 | Suzhou Hengrui Disheng Medical Co.,Ltd. | Superpipe Angiographic Catheter | 07/29/2020 |
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| K250751 | Terumo Corporation | DualView Catheter | 07/17/2025 |
| K113335 | TERUMO Corporation | HEARTRAIL III GUIDING CATHETER | 07/16/2012 |
| K033583 | TERUMO MEDICAL CORP. | PROGREAT | 12/12/2003 |
| K090040 | TERUMO MEDICAL CORP. | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | 02/06/2009 |
| K992051 | TERUMO MEDICAL CORP. | RADIFOCUS OPTITORQUE | 08/10/1999 |
| K082736 | TERUMO MEDICAL CORP. | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | 09/24/2008 |
| K142817 | TEXAS MEDICAL TECHNOLOGIES, INC. | IntraNovo 25 Microcatheter | 04/23/2015 |
| K153125 | Texas Medical Technologies, Inc. | IntraNovo Microcatheter | 01/13/2016 |
| K052637 | THEROX, INC. | THEROX INFUSION CATHETER, MODEL INCA-1 | 03/08/2006 |
| K981441 | TRINITY LABORATORIES, INC. | HEART CATH TRAY, STERILE, DISPOSABLE | 07/10/1998 |
| K221470 | Vascular Solutions LLC | Langston dual lumen catheter | 06/17/2022 |
| K101625 | VASCULAR SOLUTIONS, INC. | COHEN CROSSOVER CATHETER | 07/19/2010 |
| K073200 | VASCULAR SOLUTIONS, INC. | GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 | 02/01/2008 |
| K081846 | VASCULAR SOLUTIONS, INC. | GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 | 01/28/2009 |
| K062627 | VASCULAR SOLUTIONS, INC. | INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 | 01/05/2007 |
| K073585 | VASCULAR SOLUTIONS, INC. | INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 | 04/17/2008 |
| K061565 | VASCULAR SOLUTIONS, INC. | LANGSTON DUAL LUMEN CATHETER | 08/02/2006 |
| K170544 | Vascular Solutions, Inc. | Langston dual lumen catheter | 11/17/2017 |
| K050168 | VASCULAR SOLUTIONS, INC. | LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER | 05/18/2005 |
| K051395 | VASCULAR SOLUTIONS, INC. | LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER | 06/24/2005 |
| K062877 | VASCULAR SOLUTIONS, INC. | TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 | 01/18/2007 |
| K041909 | VASCULAR SOLUTIONS, INC. | VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) | 09/23/2004 |
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