Clearance Summary
PVS 2000 SYNCHRO2 GUIDEWIRE received FDA 510(k) clearance under submission number K053268, 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 2006-03-13.
- Submission: K053268
- Applicant / Sponsor: Boston Scientific - Precision Vascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2006-03-13
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.