510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K002612Substantially Equivalent

Bardex I.c.plus Foley Catheter with Silver Salts in Hydrogel Coating, Model 3Cc Balloon: 17008,170010,5Cc Balloon

C.R. Bard Inc, Covington GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K002612 is the FDA 510(k) clearance record for BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON, a class II device, cleared for C.R. Bard, Inc. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K002612.

Clearance record

Decision date
Received
(743 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 8195 Industrial Blvd., Covington GA
510(k) summary
Summary
Third party review
No

Clearances, product code EZL

Trailing 12 months
4 clearances under product code EZL in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EZL, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20261
November 20260