FDA 510(k) Applications for Medical Device Product Code "MSD"
(Catheter, Hemodialysis, Implanted)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K123943 | AMECO MEDICAL INDUSTRIES | AMECATH DUAL LUMEN HEMODIALYSIS CATHETER | 04/02/2013 |
| K131814 | AMECO MEDICAL INDUSTRIES | AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER | 07/26/2013 |
| K040402 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT | 04/19/2004 |
| K080400 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT | 05/13/2008 |
| K110936 | ANGIODYNAMICS, INC. | DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT | 06/10/2011 |
| K101843 | ANGIODYNAMICS, INC. | DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT | 10/20/2010 |
| K040260 | ARROW INT'L. | INTEGRAL HEMODIALYSIS CATHETER | 03/05/2004 |
| K040078 | ARROW INTERNATIONAL, INC. | CANNON II PLUS | 02/13/2004 |
| K130192 | ARROW INTERNATIONAL, INC. | NEXTSTEP RETROGRADE | 05/10/2013 |
| K040666 | ARROW INTERNATIONAL, INC. | STEP-TIP CHRONIC HEMODIALYSIS CATHETER | 05/14/2004 |
| K141051 | ARROW INTERNATIONAL, INC. | VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU | 07/07/2014 |
| K022662 | ARROW INTL., INC. | DIATEK CANNON-CATHETER, MODEL CC5500 | 05/09/2003 |
| K070572 | ASH ACCESS TECHNOLOGY, INC. | ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM | 06/26/2007 |
| K092597 | ASH ACCESS TECHNOLOGY, INC. | CENTROS CHRONIC HEMODIALYSIS CATHETER SET | 11/12/2009 |
| K053589 | BARD ACCESS SYSTEMS, INC. | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING | 04/13/2006 |
| K211410 | Bard Peripheral Vascular, Inc | GlidePath 13F Long-Term Hemodialysis Catheter | 06/04/2021 |
| K982326 | BOSTON SCIENTIFIC CORP. | MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY | 07/12/1999 |
| K012365 | BOSTON SCIENTIFIC CORP. | VAXCEL DIALYSIS CATHETER | 08/24/2001 |
| K040736 | BOSTON SCIENTIFIC CORP. | VAXCEL PLUS CHRONIC DIALYSIS CATHETER | 05/18/2004 |
| K032712 | BOSTON SCIENTIFIC CORP. | VAXCEL PLUS CHRONIC DIALYSIS CATHETER | 10/02/2003 |
| K040492 | BOSTON SCIENTIFIC CORP. | VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER | 03/16/2004 |
| K012948 | BOSTON SCIENTIFIC/MEDI-TECH | MODIFICATION TO VAXCEL DIALYSIS CATHETER | 10/03/2001 |
| K203767 | C B Bard, Inc | Pristine Long-Term Hemodialysis Catheter | 04/02/2021 |
| K200627 | C R Bard, Inc | GlidePath 10F Long-Term Dialysis Catheter | 06/22/2020 |
| K190527 | C.R. Bard | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters | 03/05/2020 |
| K090528 | C.R. BARD, INC. | DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT | 05/28/2009 |
| K090101 | C.R. BARD, INC. | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS | 02/10/2009 |
| K202150 | C.R. Bard, Inc. | GlidePath 7.5F Long-Term Dialysis Catheter | 11/18/2020 |
| K203575 | C.R. Bard, Inc. | GlidePath Retro Long-Term Hemodialysis Catheter | 07/01/2021 |
| K051748 | C.R. BARD, INC. | HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS | 08/12/2005 |
| K030020 | C.R. BARD, INC. | HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER | 06/16/2003 |
| K033294 | C.R. BARD, INC. | HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER | 11/26/2003 |
| K010567 | C.R. BARD, INC. | OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR | 03/28/2001 |
| K030277 | C.R. BARD, INC. | SOFT-CELL DUAL LUMEN CATHETERS | 08/06/2003 |
| K981994 | C.R. BARD, INC. | VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER | 09/03/1998 |
| K042672 | CARDIOMED SUPPLIES, INC. | 14F DUAL FLOATING DIALYSIS CATHETER/TRAY | 03/23/2005 |
| K982333 | COOK, INC. | MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY | 02/12/1999 |
| K123196 | COVIDIEN | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH | 01/31/2013 |
| K111817 | COVIDIEN | PALINDROME RT CHRONIC CATHETER | 08/30/2011 |
| K111372 | COVIDIEN | TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... | 08/04/2011 |
| K092205 | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL | PALINDROME P HEMODIALYSIS CATHETER | 10/30/2009 |
| K042016 | DATASCOPE CORP. | DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER | 09/23/2004 |
| K030983 | DELTEC, INC. | TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY | 04/25/2003 |
| K071202 | DERMAPORT, INC | DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) | 11/30/2007 |
| K091760 | DERMAPORT, INC | DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) | 07/20/2009 |
| K010399 | DIATEK, INC. | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) | 08/14/2001 |
| K130851 | HEALTH LINE INTERNATIONAL CORPORATION | CASCADE HEMODIALYSIS/APHERESIS CATHETER | 01/09/2014 |
| K022905 | HORIZON MEDICAL PRODUCTS, INC. | LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER | 12/13/2002 |
| K011916 | HORIZON MEDICAL PRODUCTS, INC. | SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES | 10/31/2001 |
| K062671 | KENDALL | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) | 11/03/2006 |
| K051584 | KENDALL | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY | 10/06/2005 |
| K060972 | KENDALL | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) | 08/04/2006 |
| K033676 | KENDALL | PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER | 02/20/2004 |
| K041914 | KENDALL | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER | 09/27/2004 |
| K043272 | KENDALL | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP | 12/22/2004 |
| K041006 | KENDALL | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | 05/19/2004 |
| K140492 | MARVAO MEDICAL DEVICES, LTD. | NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE | 11/13/2014 |
| K121933 | MARVAO MEDICAL DEVICES, LTD. | NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) | 03/14/2013 |
| K143567 | MARVAO MEDICAL DEVICES, LTD. | NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for l | 03/31/2015 |
| K173805 | Marvao Medical Devices, Ltd. | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Ti | 02/08/2018 |
| K133796 | MARVAO MEDICAL DEVICES, LTD. | NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), | 01/31/2014 |
| K171571 | Marvao Medical Devices, Ltd. | NexSite HD, Hemodialysis Step Tip Catheter (60cm) | 11/30/2017 |
| K161026 | MARVAO MEDICAL DEVICES, LTD. | NexSiteÖ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) | 08/09/2016 |
| K043292 | MED-CONDUIT, INC. | HEMOCATH | 03/16/2005 |
| K062901 | MED-CONDUIT, INC. | HEMOCATH II | 02/08/2007 |
| K020936 | MEDCOMP | 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL | 10/11/2002 |
| K030502 | MEDCOMP | 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 | 05/20/2003 |
| K020315 | MEDCOMP | 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL | 05/24/2002 |
| K021759 | MEDCOMP | 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 | 08/27/2002 |
| K040328 | MEDCOMP | 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER | 11/24/2004 |
| K040992 | MEDCOMP | 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 | 07/29/2004 |
| K972207 | MEDCOMP | MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM | 02/23/1998 |
| K020465 | MEDCOMP | MEDCOMP ASH SPLIT-CATH II | 05/22/2002 |
| K010306 | MEDCOMP | MEDCOMP EXCELL SPLIT TIP CATHETER | 10/03/2001 |
| K022678 | MEDCOMP | MEDCOMP SC4 | 02/24/2003 |
| K051280 | MEDCOMP | MEDCOMP SPLIT CATH II | 11/30/2005 |
| K040318 | MEDCOMP | MEDCOMP SPLIT-CATH II | 02/03/2005 |
| K130889 | MEDCOMP | SPLIT CATH RG | 04/28/2014 |
| K171618 | Medcomp (DBA Medical Components, Inc.) | Symetrex Long Term Hemodialysis Catheter | 11/16/2017 |
| K113487 | MEDICAL COMPONENTS INC | HEMO-CATH 10F, HEMO-CATH 12.5F | 03/09/2012 |
| K111651 | MEDICAL COMPONENTS INC | SPLIT CATH III | 12/08/2011 |
| K121848 | MEDICAL COMPONENTS INC | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | 09/21/2012 |
| K202176 | Medical Components Inc. (Dba Medcomp) | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes | 09/03/2020 |
| K210461 | Medical Components Inc. (Medcomp) | End Cap | 09/14/2021 |
| K994105 | MEDICAL COMPONENTS, INC. | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | 10/03/2001 |
| K012562 | MEDICAL COMPONENTS, INC. | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER | 02/08/2002 |
| K971925 | MEDICAL COMPONENTS, INC. | MEDCOMP BIO-FLEX CS CATHETER (CS100) | 02/23/1998 |
| K981125 | MEDICAL COMPONENTS, INC. | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 | 02/26/1999 |
| K003207 | MEDICAL COMPONENTS, INC. | MEDCOMP ULTRA-FLOW CATHETER | 06/12/2001 |
| K173667 | Medical Components, Inc. (Dba Medcomp) | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodia | 05/17/2018 |
| K141363 | MERIT MEDICAL SYSTEMS, INC. | CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER | 06/18/2014 |
| K151967 | Merit Medical Systems, Inc. | Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter | 04/04/2016 |
| K090148 | MERIT MEDICAL SYSTEMS, INC. | PROGUIDE CHRONIC DIALYSIS CATHETER | 04/13/2009 |
| K131260 | NAVILYST MEDICAL, INC. | NMI DIALYSIS CATHETER | 02/14/2014 |
| K072499 | NOVOSCI, INC. | NOVOFLO CATHETER LT | 10/30/2007 |
| K140884 | PHASE ONE MEDICAL | SYMETREX LONG TERM HEMODIALYSIS CATHETER | 11/26/2014 |
| K182443 | Pristine Access Technologies Ltd. | Pristine Hemodialysis Catheter | 05/31/2019 |
| K100169 | R4 VASCULAR, INC. | DURASPAN HEMODIALYSIS LONG-TERM CATHETER | 02/18/2010 |
| K091506 | R4 VASCULAR, INC. | DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 | 01/08/2010 |
| K071422 | REX MEDICAL | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET | 08/22/2007 |
| K023847 | REX MEDICAL | HEMO-STREAM HEMODIALYSIS CATHETER SET | 04/30/2003 |
| K102043 | REX MEDICAL | ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER | 11/18/2010 |
| K981365 | SHERWOOD MEDICAL CO. | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | 11/25/1998 |
| K063431 | SPIRE BIOMEDICAL INC | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 | 01/29/2007 |
| K063441 | SPIRE BIOMEDICAL INC | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 | 02/12/2007 |
| K021212 | SPIRE BIOMEDICAL INC | 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS | 05/17/2002 |
| K041559 | SPIRE BIOMEDICAL INC | 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 | 07/30/2004 |
| K040509 | SPIRE BIOMEDICAL INC | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 | 04/19/2004 |
| K073093 | SPIRE BIOMEDICAL INC | DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, | 01/22/2008 |
| K073092 | SPIRE BIOMEDICAL INC | DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, | 01/29/2008 |
| K022000 | SPIRE BIOMEDICAL INC | POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) | 07/19/2002 |
| K013160 | SPIRE BIOMEDICAL INC | POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER | 04/11/2002 |
| K060155 | SPIRE BIOMEDICAL, INC. | 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS | 05/09/2006 |
| K042858 | SPIRE BIOMEDICAL, INC. | 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS | 12/03/2004 |
| K032061 | SPIRE BIOMEDICAL, INC. | DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH | 12/23/2003 |
| K060288 | SPIRE BIOMEDICAL, INC. | RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS | 09/01/2006 |
| K102238 | Teleflex Medical, Inc. | ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER | 02/01/2011 |
| K111117 | Teleflex Medical, Inc. | CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... | 06/30/2011 |
| K111900 | Teleflex Medical, Inc. | NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER | 08/17/2011 |
| K002901 | THE KENDALL COMPANY | KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER | 03/28/2001 |
| K002902 | THE KENDALL COMPANY | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS | 04/09/2001 |
| K023023 | VASCA, INC. | LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA | 12/04/2003 |
| K001633 | VASCA, INC. | LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 | 08/24/2000 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
