Clearance Summary
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 received FDA 510(k) clearance under submission number K031700, sponsored by Medtronic Perfusion Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-08-29.
- Submission: K031700
- Applicant / Sponsor: Medtronic Perfusion Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 2003-08-29
Classification & Regulation
This clearance is catalogued under FDA product code DTN and 21 CFR 870.4400, within the Cardiovascular review panel as a Class II device.