Clearance Summary
BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) received FDA 510(k) clearance under submission number K924208, 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 1993-07-08.
- Submission: K924208
- Applicant / Sponsor: Medtronic Bio-Medicus, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2120
- Decision date: 1993-07-08
Classification & Regulation
This clearance is catalogued under FDA product code DPT and 21 CFR 870.2120, within the Cardiovascular review panel as a Class II device.