510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905008Substantially Equivalent

Flexible Intracardiac Suction Device

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

K905008 is the FDA 510(k) clearance record for FLEXIBLE INTRACARDIAC SUCTION DEVICE, a class II device, cleared for Gish Biomedical, Inc. on under FDA product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass). FDA records list 75 510(k) clearances for Gish Biomedical, Inc., from to . As of , FDA records show no recalls naming K905008.

Clearance record

Decision date
Received
(78 days to decision)
Product code
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Regulation
21 CFR 870.4420
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 DTS

Trailing 12 months

FDA records hold no clearances under product code DTS in the trailing twelve months.

FDA records show no clearances under product code DTS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260