Clearance Summary
11F GUIDING CATHETER received FDA 510(k) clearance under submission number K963663, sponsored by Boston Scientific /International Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-01-13.
- Submission: K963663
- Applicant / Sponsor: Boston Scientific /International Technologies
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1997-01-13
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.