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

Catheter, Femoral

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

LFK is the FDA product code for Catheter, Femoral, a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LFK
Device name
Catheter, Femoral
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
7

Clearances, product code LFK

By decision year
16 clearances under product code LFK with a decision year between 1982 and 1997, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LFK by decision year
YearClearances
19821
19832
19863
19872
19882
19893
19922
19971

Applicants with the most clearances

Product code LFK
Applicants holding the most 510(k) clearances under product code LFK
ApplicantClearances
Akcess Medical Products, Inc.4
Med-West, Inc.2
Medical Components, Inc.2
Quinton, Inc.2
Vas-Cath, Inc.2
Cobe Laboratories, Inc.1
Meadox Surgimed, Inc.1
Medron, LLC1
Medsurg Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code