Clearance Summary
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL received FDA 510(k) clearance under submission number K102714, sponsored by Boston Scientific Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-02-11.
- Submission: K102714
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3300
- Decision date: 2011-02-11
Classification & Regulation
This clearance is catalogued under FDA product code KRD and 21 CFR 870.3300, within the Cardiovascular review panel as a Class II device.