FDA 510(k) Applications for Medical Device Product Code "NFK"
(Kit, Repair, Catheter, Hemodialysis)

FDA 510(k) Number Applicant Device Name Decision Date
K011015 C.R. BARD, INC. CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 06/22/2001
K022561 C.R. BARD, INC. CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 08/23/2002
K030442 C.R. BARD, INC. CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 07/21/2003
K063446 C.R. BARD, INC. CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 12/15/2006
K101261 C.R. BARD, INC. CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 07/29/2010
K020430 DIATEK, INC. DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) 05/09/2002
K092797 KENDALL ACUTE AND CHRONIC CATHETER REPAIR KIT 11/19/2009
K022570 MEDCOMP MEDCOMP REPAIR KIT, MODEL ASPCRPK 10/31/2002
K011576 MEDICAL COMPONENTS, INC. MEDCOMP ASH SPLIT 06/21/2001
K062435 SPIRE BIOMEDICAL, INC. REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS 12/05/2006
K022644 SPIRE BIOMEDICAL, INC. RETRO REPAIR KIT, MODEL PRRK5 11/06/2002


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