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NFK — Kit, Repair, Catheter, Hemodialysis Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K101261c.r. bardCATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000July 29, 2010
K092797kendallACUTE AND CHRONIC CATHETER REPAIR KITNovember 19, 2009
K063446c.r. bardCATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000December 15, 2006
K062435spire biomedicalREPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERSDecember 5, 2006
K030442c.r. bardCATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000July 21, 2003
K022644spire biomedicalRETRO REPAIR KIT, MODEL PRRK5November 6, 2002
K022570medcompMEDCOMP REPAIR KIT, MODEL ASPCRPKOctober 31, 2002
K022561c.r. bardCATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000August 23, 2002
K020430diatekDIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)May 9, 2002
K011015c.r. bardCATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000June 22, 2001
K011576medical componentsMEDCOMP ASH SPLITJune 21, 2001