Clearance Summary
Affinity Fusion Oxygenator System received FDA 510(k) clearance under submission number K230640, sponsored by Medtronic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-04-06.
- Submission: K230640
- Applicant / Sponsor: Medtronic, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4350
- Decision date: 2023-04-06
Classification & Regulation
This clearance is catalogued under FDA product code DTZ and 21 CFR 870.4350, within the Cardiovascular review panel as a Class II device.