Clearance Summary
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 received FDA 510(k) clearance under submission number K071226, sponsored by Spectranetics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-06-29.
- Submission: K071226
- Applicant / Sponsor: Spectranetics Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2007-06-29
Classification & Regulation
This clearance is catalogued under FDA product code PDU and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.