510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954850Substantially Equivalent

Bard William Harvey HF-6000 Membrane Oxygenator

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

K954850 is the FDA 510(k) clearance record for BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K954850.

Clearance record

Decision date
Received
(373 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 25 Computer Dr., Haverhill MA
510(k) summary
Summary
Third party review
No

Clearances, product code DTZ

Trailing 12 months
4 clearances under product code DTZ in the twelve months to November 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DTZ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260