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

Catheter, Coude

21 CFR 876.5130 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EZC is the FDA product code for Catheter, Coude, a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
EZC
Device name
Catheter, Coude
Regulation
21 CFR 876.5130
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
7
Ingested recalls
11

Clearances, product code EZC

By decision year
7 clearances under product code EZC with a decision year between 1991 and 2022, 1991 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EZC by decision year
YearClearances
19913
19921
19951
20181
20221

Applicants with the most clearances

Product code EZC
Applicants holding the most 510(k) clearances under product code EZC
ApplicantClearances
C.R. Bard Inc4
Teleflex Medical2
Louisville Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order