510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NFKClass II

Kit, Repair, Catheter, Hemodialysis

21 CFR 876.5540 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NFK is the FDA product code for Kit, Repair, Catheter, Hemodialysis, a class II device type, regulated under 21 CFR 876.5540. FDA's definition for this code reads: "Hemodialysis Tray". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
NFK
Device name
Kit, Repair, Catheter, Hemodialysis
FDA definition
Hemodialysis Tray
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
12

Clearances, product code NFK

By decision year
11 clearances under product code NFK with a decision year between 2001 and 2010, 2002 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NFK by decision year
YearClearances
20012
20024
20031
20062
20091
20101

Applicants with the most clearances

Product code NFK
Applicants holding the most 510(k) clearances under product code NFK
ApplicantClearances
C.R. Bard Inc5
Spire Biomedical, Inc.2
Diatek, Inc.1
Kendall1
Medcomp1
Medical Components, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order