Clearance Summary
CARDIOTOMY RESERVOIR W/20 MICRON FILITER received FDA 510(k) clearance under submission number K920178, sponsored by Lifestream Int'L, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1993-05-13.
- Submission: K920178
- Applicant / Sponsor: Lifestream Int'L, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 1993-05-13
Classification & Regulation
This clearance is catalogued under FDA product code DTN and 21 CFR 870.4400, within the Cardiovascular review panel as a Class II device.