510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821442Substantially Equivalent

William Harvey Flex. Venous Reservoir

C.R. Bard Inc, Warrendale PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821442 is the FDA 510(k) clearance record for WILLIAM HARVEY FLEX. VENOUS RESERVOIR, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K821442.

Clearance record

Decision date
Received
(35 days to decision)
Product code
DTN Reservoir, Blood, Cardiopulmonary Bypass
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 110 Marshall Dr., Warrendale PA
Third party review
No

Clearances, product code DTN

Trailing 12 months
1 clearance under product code DTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260