Clearance Summary
RAILWIRE received FDA 510(k) clearance under submission number K954552, 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 1996-04-29.
- Submission: K954552
- Applicant / Sponsor: Boston Scientific /International Technologies
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 1996-04-29
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.