Clearance Summary
CSS-CARDIOPLEGIA SAFETY SYSTEM received FDA 510(k) clearance under submission number K973237, sponsored by Medtronic Bio-Medicus, 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 1998-04-27.
- Submission: K973237
- Applicant / Sponsor: Medtronic Bio-Medicus, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4370
- Decision date: 1998-04-27
Classification & Regulation
This clearance is catalogued under FDA product code DWB and 21 CFR 870.4370, within the Cardiovascular review panel as a Class II device.