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 |
|---|---|---|---|
| Jul 19, 2002 | K022000 | POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) Spire Biomedical, Inc. | MSD |
| May 24, 2002 | K020315 | 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL Medcomp | MSD |
| May 22, 2002 | K020465 | MEDCOMP ASH SPLIT-CATH II Medcomp | MSD |
| May 17, 2002 | K021212 | 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS Spire Biomedical, Inc. | MSD |
| Apr 11, 2002 | K013160 | POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER Spire Biomedical, Inc. | MSD |
| Feb 8, 2002 | K012562 | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER Medical Components, Inc. | MSD |
| Oct 31, 2001 | K011916 | SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES Horizon Medical Products, Inc. | MSD |
| Oct 3, 2001 | K994105 | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 Medical Components, Inc. | MSD |
| Oct 3, 2001 | K012948 | MODIFICATION TO VAXCEL DIALYSIS CATHETER Boston Scientific/Medi-Tech | MSD |
| Oct 3, 2001 | K010306 | MEDCOMP EXCELL SPLIT TIP CATHETER Medcomp | MSD |
| Aug 24, 2001 | K012365 | VAXCEL DIALYSIS CATHETER Boston Scientific Corp | MSD |
| Aug 14, 2001 | K010399 | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) Diatek, Inc. | MSD |
| Jun 12, 2001 | K003207 | MEDCOMP ULTRA-FLOW CATHETER Medical Components, Inc. | MSD |
| Apr 9, 2001 | K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS The Kendall Company | MSD |
| Mar 28, 2001 | K010567 | OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR C.R. Bard, Inc. | MSD |
| Mar 28, 2001 | K002901 | KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER The Kendall Company | MSD |
| Aug 24, 2000 | K001633 | LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 Vasca, Inc. | MSD |
| Jul 12, 1999 | K982326 | MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY Boston Scientific Corp | MSD |
| Feb 26, 1999 | K981125 | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 Medical Components, Inc. | MSD |
| Feb 12, 1999 | K982333 | MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY Cook, Inc. | MSD |
| Nov 25, 1998 | K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS Sherwood Medical Co. | MSD |
| Sep 3, 1998 | K981994 | VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER C.R. Bard, Inc. | MSD |
| Feb 23, 1998 | K972207 | MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM Medcomp | MSD |
| Feb 23, 1998 | K971925 | MEDCOMP BIO-FLEX CS CATHETER (CS100) Medical Components, Inc. | MSD |
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