510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070879Substantially Equivalent

Bard Malecot and Pezzer Drains

C.R. Bard Inc, Covington GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070879 is the FDA 510(k) clearance record for BARD MALECOT AND PEZZER DRAINS, a class II device, cleared for C.R. Bard, Inc. on under FDA product code FEW (Catheter, Malecot). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K070879.

Clearance record

Decision date
Received
(25 days to decision)
Product code
FEW Catheter, Malecot
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 13183 Harland Dr., Covington GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEW

Trailing 12 months

FDA records hold no clearances under product code FEW in the trailing twelve months.

FDA records show no clearances under product code FEW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FEW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260