Clearance Summary
AMPLATZER TorqVue 45x45 Delivery Sheath received FDA 510(k) clearance under submission number K163000, sponsored by Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-12-23.
- Submission: K163000
- Applicant / Sponsor: Aga Medical COrporation (Wholly Owned by St. Jude Medical CO
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2016-12-23
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.