# K982254: Cobe Sentry Smarxt  43 Micron Arterial Filter with Primegard

- Pathway: 510(k) (Abbreviated)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Sep 10, 1998 after 76 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®: named in the summary without a submission number

## Indications for use
The COBE® Sentry® SMAR, T™ 43 Micron Arterial Filter with PrimeGard® is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures for periods of up to six hours.

Source page: https://510kreport.com/device/K982254
Methodology: https://510kreport.com/methodology