Clearance Summary
PIVOT STEERABLE MICROCATHETER received FDA 510(k) clearance under submission number K050630, sponsored by Boston Scientific - Precision Vascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-03-22.
- Submission: K050630
- Applicant / Sponsor: Boston Scientific - Precision Vascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 2005-03-22
Classification & Regulation
This clearance is catalogued under FDA product code KRA and 21 CFR 870.1210, within the Cardiovascular review panel as a Class II device.