510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842813Substantially Equivalent

Heparin Coated Arterial Blood Filters

American Bentley, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842813 is the FDA 510(k) clearance record for HEPARIN COATED ARTERIAL BLOOD FILTERS, a class II device, cleared for American Bentley on under FDA product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line). FDA records list 59 510(k) clearances for American Bentley, from to . As of , FDA records show no recalls naming K842813.

Clearance record

Decision date
Received
(174 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
American Bentley 17502 Armstrong Ave., Irvine 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