510(k) K122760
K122760 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE". The FDA issued a decision of Substantially Equivalent on December 7, 2012. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2012
- Date Received
- September 10, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Device Class
- Class II
- Regulation Number
- 870.4260
- Review Panel
- CV
- Submission Type