510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982254Substantially Equivalent

Cobe Sentry Smarxt 43 Micron Arterial Filter with Primegard

LivaNova USA, Inc., Arvada CO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K982254 is the FDA 510(k) clearance record for COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD, a class II device, cleared for Cobe Cardiovascular, Inc. on under FDA product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line). FDA records list 49 510(k) clearances for LivaNova USA, INC., from to . As of , FDA records show no recalls naming K982254.

Clearance record

Decision date
Received
(76 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
Cobe Cardiovascular, Inc. 14401 W. 65th Way, Arvada CO
510(k) summary
Summary
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