Clearance Summary
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 received FDA 510(k) clearance under submission number K022107, sponsored by Cardiomedics, 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 2002-08-08.
- Submission: K022107
- Applicant / Sponsor: Cardiomedics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 2002-08-08
Classification & Regulation
This clearance is catalogued under FDA product code DRN and 21 CFR 870.5225, within the Cardiovascular review panel as a Class II device.