Clearance Summary
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER received FDA 510(k) clearance under submission number K083919, sponsored by Invatec Innovative Technologies, S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-03-13.
- Submission: K083919
- Applicant / Sponsor: Invatec Innovative Technologies, S.R.L.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2009-03-13
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.