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

Catheter, Malecot

21 CFR 876.5090 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FEW is the FDA product code for Catheter, Malecot, a class II device type, regulated under 21 CFR 876.5090. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FEW
Device name
Catheter, Malecot
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code FEW

By decision year
6 clearances under product code FEW with a decision year between 1992 and 2014, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FEW by decision year
YearClearances
19921
19951
19961
19981
20071
20141

Applicants with the most clearances

Product code FEW
Applicants holding the most 510(k) clearances under product code FEW
ApplicantClearances
C.R. Bard Inc1
Cook Incorporated1
Argon Medical Devices, Inc1
Medical Device Technologies, Inc.1
Olympic Medical Corp.1
Technical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code