510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K833644Substantially Equivalent

Filter Purge Line Ec-Fpl Series

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

K833644 is the FDA 510(k) clearance record for FILTER PURGE LINE EC-FPL SERIES, a class II device, cleared for Gish Biomedical, Inc. on under FDA product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass). FDA records list 75 510(k) clearances for Gish Biomedical, Inc., from to . As of , FDA records show no recalls naming K833644.

Clearance record

Decision date
Received
(439 days to decision)
Product code
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Regulation
21 CFR 870.4290
Device class
Class II
Review panel
Cardiovascular
Applicant
Gish Biomedical, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DTL

Trailing 12 months

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

FDA records show no clearances under product code DTL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTL, 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