Clearance Summary
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR received FDA 510(k) clearance under submission number K984456, sponsored by Cobe Cardiovascular, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-01-11.
- Submission: K984456
- Applicant / Sponsor: Cobe Cardiovascular, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 1999-01-11
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.