510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882414Substantially Equivalent

Blood Reservoir, Cardiopulmonary Bypass

Gish Biomedical, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882414 is the FDA 510(k) clearance record for BLOOD RESERVOIR, CARDIOPULMONARY BYPASS, a class II device, cleared for Gish Biomedical, Inc. on under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass). FDA records list 75 510(k) clearances for Gish Biomedical, Inc., from to . As of , FDA records show no recalls naming K882414.

Clearance record

Decision date
Received
(175 days to decision)
Product code
DTN Reservoir, Blood, Cardiopulmonary Bypass
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
Gish Biomedical, Inc. 2350 S. Pullman Ave., Santa Ana CA
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