NFK — Kit, Repair, Catheter, Hemodialysis Class II
FDA product code NFK covers "Kit, Repair, Catheter, Hemodialysis", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NFK
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Hemodialysis Tray
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K101261 | c.r. bard | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | July 29, 2010 |
| K092797 | kendall | ACUTE AND CHRONIC CATHETER REPAIR KIT | November 19, 2009 |
| K063446 | c.r. bard | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | December 15, 2006 |
| K062435 | spire biomedical | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS | December 5, 2006 |
| K030442 | c.r. bard | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | July 21, 2003 |
| K022644 | spire biomedical | RETRO REPAIR KIT, MODEL PRRK5 | November 6, 2002 |
| K022570 | medcomp | MEDCOMP REPAIR KIT, MODEL ASPCRPK | October 31, 2002 |
| K022561 | c.r. bard | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | August 23, 2002 |
| K020430 | diatek | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) | May 9, 2002 |
| K011015 | c.r. bard | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | June 22, 2001 |
| K011576 | medical components | MEDCOMP ASH SPLIT | June 21, 2001 |