Panels › Gastroenterology, Urology › Product code MSD · Class 2
Catheter, Hemodialysis, Implanted
Regulation 876.5540
0510(k)s in 12 months (124 all time)
8recalls in 12 months (270 all time)
257recalls that name a 510(k)
Top companies in MSD
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien | 3 | 71 |
| Spire Biomedical, Inc. | 13 | 48 |
| Arrow International, Inc. | 4 | 50 |
| AngioDynamics, Inc. | 4 | 34 |
| Bard Peripheral Vascular, Inc. | 1 | 30 |
| Angiodynamics Worldwide Headquarters | 0 | 16 |
| Medcomp | 13 | 0 |
| C. R. Bard | 12 | 0 |
| Kendall | 9 | 0 |
| Marvao Medical Devices, Ltd. | 7 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2008 | K073092 | DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, Spire Biomedical, Inc. | MSD |
| Jan 22, 2008 | K073093 | DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, Spire Biomedical, Inc. | MSD |
| Nov 30, 2007 | K071202 | DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) Dermaport, Inc. | MSD |
| Oct 30, 2007 | K072499 | NOVOFLO CATHETER LT Novosci, Inc. | MSD |
| Aug 22, 2007 | K071422 | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET Rex Medical | MSD |
| Jun 26, 2007 | K070572 | ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM Ash Access Technology, Inc. | MSD |
| Feb 12, 2007 | K063441 | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 Spire Biomedical, Inc. | MSD |
| Feb 8, 2007 | K062901 | HEMOCATH II Med-Conduit, Inc. | MSD |
| Jan 29, 2007 | K063431 | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 Spire Biomedical, Inc. | MSD |
| Nov 3, 2006 | K062671 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) Kendall | MSD |
| Sep 1, 2006 | K060288 | RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS Spire Biomedical, Inc. | MSD |
| Aug 4, 2006 | K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) Kendall | MSD |
| May 9, 2006 | K060155 | 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS Spire Biomedical, Inc. | MSD |
| Apr 13, 2006 | K053589 | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING Bard Access Systems, Inc. | MSD |
| Nov 30, 2005 | K051280 | MEDCOMP SPLIT CATH II Medcomp | MSD |
| Oct 6, 2005 | K051584 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY Kendall | MSD |
| Aug 12, 2005 | K051748 | HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS C.R. Bard, Inc. | MSD |
| Mar 23, 2005 | K042672 | 14F DUAL FLOATING DIALYSIS CATHETER/TRAY Cardio Med Supplies, Inc., CA | MSD |
| Mar 16, 2005 | K043292 | HEMOCATH Med-Conduit, Inc. | MSD |
| Feb 3, 2005 | K040318 | MEDCOMP SPLIT-CATH II Medcomp | MSD |
| Dec 22, 2004 | K043272 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP Kendall | MSD |
| Dec 3, 2004 | K042858 | 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS Spire Biomedical, Inc. | MSD |
| Nov 24, 2004 | K040328 | 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER Medcomp | MSD |
| Sep 27, 2004 | K041914 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER Kendall | MSD |
| Sep 23, 2004 | K042016 | DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER Datascope Corp. | MSD |
| Jul 30, 2004 | K041559 | 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 Spire Biomedical, Inc. | MSD |
| Jul 29, 2004 | K040992 | 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 Medcomp | MSD |
| May 19, 2004 | K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR Kendall | MSD |
| May 18, 2004 | K040736 | VAXCEL PLUS CHRONIC DIALYSIS CATHETER Boston Scientific Corp | MSD |
| May 14, 2004 | K040666 | STEP-TIP CHRONIC HEMODIALYSIS CATHETER Arrow International, Inc. | MSD |
| Apr 19, 2004 | K040509 | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 Spire Biomedical, Inc. | MSD |
| Apr 19, 2004 | K040402 | ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc. | MSD |
| Mar 16, 2004 | K040492 | VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER Boston Scientific Corp | MSD |
| Mar 5, 2004 | K040260 | INTEGRAL HEMODIALYSIS CATHETER Arrow Int'L. | MSD |
| Feb 20, 2004 | K033676 | PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER Kendall | MSD |
| Feb 13, 2004 | K040078 | CANNON II PLUS Arrow International, Inc. | MSD |
| Dec 23, 2003 | K032061 | DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH Spire Biomedical, Inc. | MSD |
| Dec 4, 2003 | K023023 | LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA Vasca, Inc. | MSD |
| Nov 26, 2003 | K033294 | HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER C.R. Bard, Inc. | MSD |
| Oct 2, 2003 | K032712 | VAXCEL PLUS CHRONIC DIALYSIS CATHETER Boston Scientific Corp | MSD |
| Aug 6, 2003 | K030277 | SOFT-CELL DUAL LUMEN CATHETERS C.R. Bard, Inc. | MSD |
| Jun 16, 2003 | K030020 | HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER C.R. Bard, Inc. | MSD |
| May 20, 2003 | K030502 | 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 Medcomp | MSD |
| May 9, 2003 | K022662 | DIATEK CANNON-CATHETER, MODEL CC5500 Arrow Intl., Inc. | MSD |
| Apr 30, 2003 | K023847 | HEMO-STREAM HEMODIALYSIS CATHETER SET Rex Medical | MSD |
| Apr 25, 2003 | K030983 | TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY Deltec, Inc. | MSD |
| Feb 24, 2003 | K022678 | MEDCOMP SC4 Medcomp | MSD |
| Dec 13, 2002 | K022905 | LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER Horizon Medical Products, Inc. | MSD |
| Oct 11, 2002 | K020936 | 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL Medcomp | MSD |
| Aug 27, 2002 | K021759 | 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 Medcomp | MSD |
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