Clearance Summary
SPECTRANETICS LLD CS, MODEL 518-039 received FDA 510(k) clearance under submission number K043401, 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 2005-03-16.
- Submission: K043401
- Applicant / Sponsor: Spectranetics Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1380
- Decision date: 2005-03-16
Classification & Regulation
This clearance is catalogued under FDA product code DRB and 21 CFR 870.1380, within the Cardiovascular review panel as a Class II device.