Clearance Summary
BPX80 BIO-PUMP (BPX80) received FDA 510(k) clearance under submission number K973011, 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 1998-02-25.
- Submission: K973011
- Applicant / Sponsor: Medtronic Bio-Medicus, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4360
- Decision date: 1998-02-25
Classification & Regulation
This clearance is catalogued under FDA product code KFM and 21 CFR 870.4360, within the Cardiovascular review panel as a Class II device.