Clearance Summary
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 received FDA 510(k) clearance under submission number K052570, sponsored by Cardiacassist, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-01-17.
- Submission: K052570
- Applicant / Sponsor: Cardiacassist, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2006-01-17
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.