NFK · Class II · 21 CFR 876.5540

FDA Product Code NFK: Kit, Repair, Catheter, Hemodialysis

Hemodialysis Tray

Leading manufacturers include C.R. Bard, Inc., Spire Biomedical, Inc. and Medical Components, Inc..

11
Total
11
Cleared
77d
Avg days
2001
Since

FDA 510(k) Cleared Kit, Repair, Catheter, Hemodialysis Devices (Product Code NFK)

11 devices
1–11 of 11
Cleared Jul 29, 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K101261
C.R. Bard, Inc.
Gastroenterology & Urology · 85d
Cleared Nov 19, 2009
ACUTE AND CHRONIC CATHETER REPAIR KIT
K092797
Kendall
Gastroenterology & Urology · 69d
Cleared Dec 15, 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K063446
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 05, 2006
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
K062435
Spire Biomedical, Inc.
Gastroenterology & Urology · 106d
Cleared Jul 21, 2003
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K030442
C.R. Bard, Inc.
Gastroenterology & Urology · 160d
Cleared Nov 06, 2002
RETRO REPAIR KIT, MODEL PRRK5
K022644
Spire Biomedical, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 31, 2002
MEDCOMP REPAIR KIT, MODEL ASPCRPK
K022570
Medcomp
Gastroenterology & Urology · 90d
Cleared Aug 23, 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K022561
C.R. Bard, Inc.
Gastroenterology & Urology · 21d
Cleared May 09, 2002
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
K020430
Diatek, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 22, 2001
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K011015
C.R. Bard, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 21, 2001
MEDCOMP ASH SPLIT
K011576
Medical Components, Inc.
Gastroenterology & Urology · 30d

About Product Code NFK - Regulatory Context