Clearance Summary
OPTI-PLAST XL 5.5 F PTA CATHETER received FDA 510(k) clearance under submission number K970725, sponsored by Vas-Cath, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-05-09.
- Submission: K970725
- Applicant / Sponsor: Vas-Cath, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1997-05-09
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.