Clearance Summary
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV received FDA 510(k) clearance under submission number K052348, sponsored by Volcano Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-12-02.
- Submission: K052348
- Applicant / Sponsor: Volcano Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2005-12-02
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.