Clearance Summary
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER received FDA 510(k) clearance under submission number K020012, 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 2002-01-29.
- Submission: K020012
- Applicant / Sponsor: Boston Scientific/Medi-Tech
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2002-01-29
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.