510(k) K230640
K230640 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Affinity Fusion Oxygenator System". The FDA issued a decision of Substantially Equivalent on April 6, 2023. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2023
- Date Received
- March 8, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type