Panels › Gastroenterology, Urology › Product code NFK · Class 2
Kit, Repair, Catheter, Hemodialysis
Regulation 876.5540
0510(k)s in 12 months (11 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in NFK
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Components, Inc dba MedComp | 0 | 10 |
| C.R. Bard, Inc. | 5 | 0 |
| Arrow International Inc | 0 | 2 |
| Spire Biomedical, Inc. | 2 | 0 |
| Diatek, Inc. | 1 | 0 |
| Kendall | 1 | 0 |
| Medcomp | 1 | 0 |
| Medical Components, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 2010 | K101261 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. | NFK |
| Nov 19, 2009 | K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT Kendall | NFK |
| Dec 15, 2006 | K063446 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. | NFK |
| Dec 5, 2006 | K062435 | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS Spire Biomedical, Inc. | NFK |
| Jul 21, 2003 | K030442 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. | NFK |
| Nov 6, 2002 | K022644 | RETRO REPAIR KIT, MODEL PRRK5 Spire Biomedical, Inc. | NFK |
| Oct 31, 2002 | K022570 | MEDCOMP REPAIR KIT, MODEL ASPCRPK Medcomp | NFK |
| Aug 23, 2002 | K022561 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. | NFK |
| May 9, 2002 | K020430 | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) Diatek, Inc. | NFK |
| Jun 22, 2001 | K011015 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. | NFK |
| Jun 21, 2001 | K011576 | MEDCOMP ASH SPLIT Medical Components, Inc. | NFK |
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