Clearance Summary
IMAGER II ANGIOGRAPHIC CATHETER received FDA 510(k) clearance under submission number K011664, sponsored by Boston Scientific/Medi-Tech. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-09-07.
- Submission: K011664
- Applicant / Sponsor: Boston Scientific/Medi-Tech
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2001-09-07
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.