510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851323Substantially Equivalent

Amendment William Harvey H-4300 Cardiopulmonary Su

C.R. Bard Inc, Murray Hill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851323 is the FDA 510(k) clearance record for AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K851323.

Clearance record

Decision date
Received
(130 days to decision)
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation
21 CFR 870.4210
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 111 Spring St., Murray Hill NJ
Third party review
No

Clearances, product code DWF

Trailing 12 months
8 clearances under product code DWF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20262
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261