Clearance Summary
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD received FDA 510(k) clearance under submission number K982254, sponsored by Cobe Cardiovascular, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-09-10.
- Submission: K982254
- Applicant / Sponsor: Cobe Cardiovascular, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4260
- Decision date: 1998-09-10
Classification & Regulation
This clearance is catalogued under FDA product code DTM and 21 CFR 870.4260, within the Cardiovascular review panel as a Class II device.