510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944219Substantially Equivalent

Single Pass Blood Cardioplegia Spbc System Components

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

K944219 is the FDA 510(k) clearance record for SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS, a class II device, cleared for Gish Biomedical, Inc. on under FDA product code DTR (Heat-Exchanger, Cardiopulmonary Bypass). FDA records list 75 510(k) clearances for Gish Biomedical, Inc., from to . As of , FDA records show no recalls naming K944219.

Clearance record

Decision date
Received
(305 days to decision)
Product code
DTR Heat-Exchanger, Cardiopulmonary Bypass
Regulation
21 CFR 870.4240
Device class
Class II
Review panel
Cardiovascular
Applicant
Gish Biomedical, Inc. 2681 Kelvin Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code DTR

Trailing 12 months
1 clearance under product code DTR in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260