510(k) K973011
K973011 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "BPX80 BIO-PUMP (BPX80)". The FDA issued a decision of Substantially Equivalent on February 25, 1998. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1998
- Date Received
- August 13, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4360
- Review Panel
- CV
- Submission Type