510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851003Substantially Equivalent

Arterial Filter Afs-Xx /Filter Holder Afs-Hxx

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

K851003 is the FDA 510(k) clearance record for ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX, a class II device, cleared for Gish Biomedical, Inc. on under FDA product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line). FDA records list 75 510(k) clearances for Gish Biomedical, Inc., from to . As of , FDA records show no recalls naming K851003.

Clearance record

Decision date
Received
(139 days to decision)
Product code
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation
21 CFR 870.4260
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 DTM

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