Clearance Summary
TAMARIN BLUE PTCA RX DILATATION CATHETER received FDA 510(k) clearance under submission number K112735, sponsored by Natec Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-11-02.
- Submission: K112735
- Applicant / Sponsor: Natec Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5100
- Decision date: 2012-11-02
Classification & Regulation
This clearance is catalogued under FDA product code LOX and 21 CFR 870.5100, within the Cardiovascular review panel as a Class II device.