Clearance Summary
AMPLATZER TORQVUE FX received FDA 510(k) clearance under submission number K121611, sponsored by Aga Medical Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-08-23.
- Submission: K121611
- Applicant / Sponsor: Aga Medical Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2012-08-23
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.