Clearance Summary
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM received FDA 510(k) clearance under submission number K042473, sponsored by Cobe Cardiovascular, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2004-11-19.
- Submission: K042473
- Applicant / Sponsor: Cobe Cardiovascular, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 2004-11-19
Classification & Regulation
This clearance is catalogued under FDA product code JQC and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.