Clearance Summary
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 received FDA 510(k) clearance under submission number K022138, 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 2002-09-23.
- Submission: K022138
- Applicant / Sponsor: Spectranetics Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2002-09-23
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.