Product Code: NFK FDA class 2 21 CFR 876.5540

Kit, Repair, Catheter, Hemodialysis

Gastroenterology, Urology

The Kit, Repair, Catheter, Hemodialysis (product code NFK) is a kit used to repair hemodialysis catheters, providing components and materials to restore catheter function and maintain patency in patients on renal replacement therapy. Per its definition, it is intended to enhance intravascular catheter performance and maintain vascular access patency. It is classified as an FDA Class 2 device within the Gastroenterology and Urology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: NFK
Device Class: FDA class 2
Regulation Number: 876.5540
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

Hemodialysis Tray

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K101261	CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000	Jul 29, 2010	Substantially Equivalent	C.R. Bard, Inc.
K092797	ACUTE AND CHRONIC CATHETER REPAIR KIT	Nov 19, 2009	Unknown	Kendall
K063446	CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000	Dec 15, 2006	Substantially Equivalent	C.R. Bard, Inc.
K062435	REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS	Dec 05, 2006	Substantially Equivalent	Spire Biomedical, Inc.
K030442	CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000	Jul 21, 2003	Substantially Equivalent	C.R. Bard, Inc.
K022644	RETRO REPAIR KIT, MODEL PRRK5	Nov 06, 2002	Unknown	Spire Biomedical, Inc.
K022570	MEDCOMP REPAIR KIT, MODEL ASPCRPK	Oct 31, 2002	Substantially Equivalent	Medcomp
K022561	CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000	Aug 23, 2002	Substantially Equivalent	C.R. Bard, Inc.
K020430	DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)	May 09, 2002	Substantially Equivalent	Diatek, Inc.
K011015	CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000	Jun 22, 2001	Substantially Equivalent	C.R. Bard, Inc.
K011576	MEDCOMP ASH SPLIT	Jun 21, 2001	Substantially Equivalent	Medical Components, Inc.