Clearance Summary
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 received FDA 510(k) clearance under submission number K061369, sponsored by Cardiacassist, 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 2006-08-22.
- Submission: K061369
- Applicant / Sponsor: Cardiacassist, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4380
- Decision date: 2006-08-22
Classification & Regulation
This clearance is catalogued under FDA product code DWA and 21 CFR 870.4380, within the Cardiovascular review panel as a Class II device.