Product code NFK— Gastroenterology, Urology
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- Classification name
- Kit, Repair, Catheter, Hemodialysis
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 11
- First cleared
- Most recent
FDA classification definition
“Hemodialysis Tray”
Market context for product code NFK
FDA has cleared devices under product code NFK between 2001 and 2010, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2010
- 2009
- 2006
- 2003
- 2002
- 2001
Top applicants under product code NFK
Recent clearances under product code NFK
- K101261 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT
- K063446 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
- K030442 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K022644 — RETRO REPAIR KIT, MODEL PRRK5
- K022570 — MEDCOMP REPAIR KIT, MODEL ASPCRPK
- K022561 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
- K011015 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K011576 — MEDCOMP ASH SPLIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.