Clearance Summary
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR received FDA 510(k) clearance under submission number K004046, sponsored by Cobe Cardiovascular, 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 2001-04-26.
- Submission: K004046
- Applicant / Sponsor: Cobe Cardiovascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4230
- Decision date: 2001-04-26
Classification & Regulation
This clearance is catalogued under FDA product code DTP and 21 CFR 870.4230, within the Cardiovascular review panel as a Class II device.