Clearance Summary
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER received FDA 510(k) clearance under submission number K982385, sponsored by Porous Media Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-02-01.
- Submission: K982385
- Applicant / Sponsor: Porous Media Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4280
- Decision date: 1999-02-01
Classification & Regulation
This clearance is catalogued under FDA product code KRJ and 21 CFR 870.4280, within the Cardiovascular review panel as a Class II device.