FDA 510(k) Applications Submitted by Merit Medical Systems, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K170668 03/06/2017 HeartSpan Steerable Sheath Introducer Merit Medical Systems, Inc.
K132164 07/12/2013 HEARTSPAN STEERABLE INTRODUCER KIT MERIT MEDICAL SYSTEMS, INC.
K152116 07/30/2015 5.5 F Worley Advanced LVI Lateral Vein Introducer MERIT MEDICAL SYSTEMS, INC.
K152381 08/24/2015 Prelude SNAP Splittable Hydrophilic Sheath Introducer MERIT MEDICAL SYSTEMS, INC.
K132720 08/30/2013 HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH MERIT MEDICAL SYSTEMS, INC.
K143255 11/13/2014 Prelude SNAP Splittable Sheath Introducer MERIT MEDICAL SYSTEMS, INC.
K063733 12/18/2006 RESOLVE BILIARY DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC.
K180450 02/20/2018 Corvocet Biopsy System Merit Medical Systems, Inc.
K162777 10/03/2016 Squirt Fluid Delivery System Merit Medical Systems, Inc.
K163597 12/21/2016 VacLok AT Vacuum Syringe Merit Medical Systems, Inc.
K093947 12/23/2009 ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC MERIT MEDICAL SYSTEMS, INC.
K121832 06/22/2012 RESOLVE BILIARY LOCKING DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC.
K000659 02/28/2000 MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT MERIT MEDICAL SYSTEMS, INC.
K990975 03/23/1999 IN-LINE HEMOSTASIS VALVE MERIT MEDICAL SYSTEMS, INC.
K991619 05/11/1999 FOUNTAIN Infusion Catheter and Occluding Guide Wire MERIT MEDICAL SYSTEMS, INC.
K992231 07/02/1999 FOUNTAIN Infusion Catheter and Occluding Guide Wire MERIT MEDICAL SYSTEMS, INC.
K002289 07/27/2000 INQWIRE DIAGNOSTIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K993057 09/13/1999 MBA MERIT MEDICAL SYSTEMS, INC.
K003078 10/03/2000 MERIT DRAINAGE DEPOT MERIT MEDICAL SYSTEMS, INC.
K993341 10/05/1999 INTELLISYSTEM II COLOR MONITOR MERIT MEDICAL SYSTEMS, INC.
K994253 12/17/1999 VACLOK SYRINGE MERIT MEDICAL SYSTEMS, INC.
K140475 02/26/2014 ROTATING ADAPTERS MERIT MEDICAL SYSTEMS, INC.
K171362 05/09/2017 Merit Syringe Merit Medical Systems, Inc.
K152783 09/25/2015 Merit 20 mL Syringe Merit Medical Systems, Inc.
K163084 11/03/2016 Merit Coronary Control Syringe Merit Medical Systems, Inc.
K173601 11/21/2017 Merit Syringe Merit Medical Systems, Inc.
K122190 07/24/2012 PRELUDE 7F SHORT SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC.
K140382 02/14/2014 AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY MERIT MEDICAL SYSTEMS, INC.
K011811 06/11/2001 MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE MERIT MEDICAL SYSTEMS, INC.
K160107 01/19/2016 DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Merit Medical Systems, Inc.
K130566 03/04/2013 BASIXTOUCH MERIT MEDICAL SYSTEMS, INC.
K102273 08/11/2010 MERIT BIPOLAR COAGULATION PROBE MERIT MEDICAL SYSTEMS, INC.
K153672 12/21/2015 basixTOUCH40 Inflation Syringe MERIT MEDICAL SYSTEMS, INC.
K251265 04/24/2025 Resilience Fully Covered Esophageal Stent System Merit Medical Systems, Inc.
K211405 05/06/2021 Prelude Guide Sheath Merit Medical Systems, Inc.
K161392 05/19/2016 Elation Pulmonary Balloon Dilation MERIT MEDICAL SYSTEMS, INC.
K151925 07/13/2015 Elation Wireguided Balloon Dilation Catheter MERIT MEDICAL SYSTEMS, INC.
K122089 07/16/2012 OSTIAL PRO STENT POSITIONING SYSTEM MERIT MEDICAL SYSTEMS, INC.
K213434 10/22/2021 Elation Pulmonary Balloon Dilation Catheter Merit Medical Systems, Inc.
K173750 12/08/2017 Prelude IDeal Hydrophilic Sheath Introducer Merit Medical Systems, Inc.
K962129 06/03/1996 CONTINUOUS FLUSH DEVICE MERIT MEDICAL SYSTEMS, INC.
K973230 08/27/1997 MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) MERIT MEDICAL SYSTEMS, INC.
K973708 09/29/1997 TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL MERIT MEDICAL SYSTEMS, INC.
K974067 10/27/1997 FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K961794 05/09/1996 FLUID ADMINISTRATION SET - CONTRAST MANAGER MERIT MEDICAL SYSTEMS, INC.
K981417 04/20/1998 Squirt Fluid Delivery System MERIT MEDICAL SYSTEMS, INC.
K202610 09/09/2020 Ventrax Delivery System Merit Medical Systems, Inc.
K233268 09/29/2023 Impress Angiographic Catheter Merit Medical Systems, Inc.
K232609 08/28/2023 Micro AceÖ Advanced Micro Access System Merit Medical Systems, Inc.
K141408 05/28/2014 RESOLVE BILIARY LOCKING DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC.
K092343 08/04/2009 EN SNARE ENDOVASCULAR SNARE SYSTEM MERIT MEDICAL SYSTEMS, INC.
K153337 11/19/2015 Corvocet Biopsy System MERIT MEDICAL SYSTEMS, INC.
K162988 10/27/2016 PreludeSYNC Radial Compression Device Merit Medical Systems, Inc.
K151373 05/21/2015 Corvocet Coaxial Introducer Merit Medical Systems, Inc.
K172117 07/13/2017 Prelude Pursuit Splittable Sheath Introducer Merit Medical Systems, Inc.
K240261 01/31/2024 Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) Merit Medical Systems, Inc.
K230418 02/16/2023 Mighty Wire Guide Wire Merit Medical Systems, Inc.
K241521 05/29/2024 Prelude Small O.D. Introducer Guide Wire Merit Medical Systems, Inc.
K100319 02/04/2010 MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L MERIT MEDICAL SYSTEMS, INC.
K212675 08/24/2021 Aspira Peritoneal Drainage System Merit Medical Systems, Inc.
K212696 08/25/2021 Aspira Pleural Drainage System Merit Medical Systems, Inc.
K231246 05/01/2023 VentraxÖ Delivery System (VTR851) Merit Medical Systems, Inc.
K242873 09/23/2024 VentraxÖ Delivery System Merit Medical Systems, Inc.
K070159 01/17/2007 PRELUDE SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC.
K050962 04/18/2005 MERIT PRELUDE SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC.
K031691 06/02/2003 MERIT MAK (MINI ACCESS KIT) MERIT MEDICAL SYSTEMS, INC.
K082063 07/21/2008 PRELUDE SHORT SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC.
K040138 01/22/2004 VICEROY INFLATION DEVICE MERIT MEDICAL SYSTEMS, INC.
K182279 08/22/2018 Merit Syringe Merit Medical Systems, Inc.
K111611 06/09/2011 ENDOMAXX FULLY COVERED ESOPHAGEAL STENT MERIT MEDICAL SYSTEMS, INC.
K031922 06/23/2003 CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W MERIT MEDICAL SYSTEMS, INC.
K212199 07/14/2021 ASAP Aspiration Catheter, ASAPLP Aspiration Catheter Merit Medical Systems, Inc.
K223872 12/23/2022 Low Profile Companion Sheath Merit Medical Systems, Inc.
K130259 02/01/2013 BEARING NSPVA EMBOLIZATION PARTICLES MERIT MEDICAL SYSTEMS, INC.
K100569 03/01/2010 MERIT EMBOLECTOMY CATHETER MODEL ASAP100 MERIT MEDICAL SYSTEMS, INC.
K211525 05/17/2021 SwiftNINJA Steerable Microcatheter Merit Medical Systems, Inc.
K191608 06/17/2019 Impress Angiographic Catheter Merit Medical Systems, Inc.
K161921 07/13/2016 SwiftNINJA Microcatheter MERIT MEDICAL SYSTEMS, INC.
K170532 02/22/2017 True Form Reshapable Guide Wire Merit Medical Systems, Inc.
K120644 03/02/2012 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K110643 03/04/2011 MERIT MARQUIS FLOW SWITCH MERIT MEDICAL SYSTEMS, INC.
K170933 03/29/2017 Merit Hydrophilic Guide Wire Merit Medical Systems, Inc.
K201595 06/12/2020 Merit Hydrophilic Guide Wire Merit Medical Systems, Inc.
K122088 07/16/2012 MERIT ONE SNARE SYSTEM MERIT MEDICAL SYSTEMS, INC.
K142265 08/15/2014 ONE Snare Endovascular Microsnare System MERIT MEDICAL SYSTEMS, INC.
K233813 11/30/2023 Bearing nsPVA ExpressÖ Merit Medical Systems, Inc.
K143429 12/01/2014 Passage Hemostasis Valve MERIT MEDICAL SYSTEMS, INC.
K193507 12/18/2019 Merit ONE Snare System Merit Medical Systems, Inc.
K163575 12/19/2016 Inqwire Diagnostic Guide Wire Merit Medical Systems, Inc.
K130588 03/07/2013 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K131710 06/11/2013 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K141295 05/19/2014 MERIT HYDROPHILIC GUIDEWIRE MERIT MEDICAL SYSTEMS, INC.
K150257 02/03/2015 PreludeEASE Hydrophilic Sheath Introducer Merit Medical Systems, Inc.
K140543 03/04/2014 PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC.
K130791 03/22/2013 PRELUDE SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC.
K121051 04/06/2012 CONCIERGE GUIDING CATHETER MERIT MEDICAL SYSTEMS, INC.
K111091 04/19/2011 MERIT MEDICAL 20 ML SYRINGE MERIT MEDICAL SYSTEMS, INC.
K201907 07/09/2020 ClariVein IC Merit Medical Systems, Inc.
K082613 09/08/2008 MERIT MICROCATHETER MERIT MEDICAL SYSTEMS, INC.
K093004 09/28/2009 IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING MERIT MEDICAL SYSTEMS, INC.
K142636 09/17/2014 Merit 10mL Syringe Merit Medical Systems, Inc.
K250909 03/26/2025 Prelude Wave Hydrophilic Sheath Introducer Merit Medical Systems, Inc.
K172081 07/10/2017 Maestro Microcatheter Merit Medical Systems, Inc.
K242229 07/30/2024 Micro Ace Gold Advanced Micro Access System Merit Medical Systems, Inc.
K173548 11/16/2017 Merit Pursue Microcatheter Merit Medical Systems, Inc.
K212882 09/10/2021 SCOUT BX Delivery System Merit Medical Systems, Inc.
K191596 06/17/2019 Arcadia Balloon Catheter Merit Medical Systems, Inc.
K072556 09/10/2007 HEMOSTASIS VALVE MERIT MEDICAL SYSTEMS, INC.
K073035 10/29/2007 PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS MERIT MEDICAL SYSTEMS, INC.
K140608 03/10/2014 MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE MERIT MEDICAL SYSTEMS, INC.
K133230 10/21/2013 INQWIRE DIAGNOSTIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K053171 11/14/2005 MERIT IMPRESS DIAGNOSTIC CATHETER MERIT MEDICAL SYSTEMS, INC.
K123609 11/21/2012 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K083576 12/03/2008 MISER CONTRAST MANAGEMENT SYSTEM MERIT MEDICAL SYSTEMS, INC.
K022117 07/01/2002 MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 MERIT MEDICAL SYSTEMS, INC.
K024052 12/06/2002 MERIT MEDICAL 1-ML SYRINGE MERIT MEDICAL SYSTEMS, INC.
K090148 01/21/2009 PROGUIDE CHRONIC DIALYSIS CATHETER MERIT MEDICAL SYSTEMS, INC.
K140513 02/28/2014 MERIT SAFETY INTRODUCER NEEDLE MERIT MEDICAL SYSTEMS, INC.
K141363 05/23/2014 CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER MERIT MEDICAL SYSTEMS, INC.
K091584 06/02/2009 MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K132155 07/12/2013 Merit ASAPLP Aspiration Catheter MERIT MEDICAL SYSTEMS, INC.
K151967 07/16/2015 Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter Merit Medical Systems, Inc.
K092303 07/29/2009 MERIT LAUREATE HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC.
K172637 09/01/2017 HeRO Graft Merit Medical Systems, Inc.
K213845 12/09/2021 HeRO Graft Merit Medical Systems, Inc.
K203724 12/21/2020 HeRO Graft, HeRO Adapter Merit Medical Systems, Inc.
K090084 01/12/2009 ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE MERIT MEDICAL SYSTEMS, INC.
K083523 11/26/2008 MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE MERIT MEDICAL SYSTEMS, INC.
K132409 08/02/2013 CONCIERGE GUIDING CATHETER MERIT MEDICAL SYSTEMS, INC.
K072552 09/10/2007 MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE MERIT MEDICAL SYSTEMS, INC.


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