Clearance Summary
FLOSCOPE SUPER VASCULAR LAB received FDA 510(k) clearance under submission number K943200, sponsored by Advance Medical Device, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-11-21.
- Submission: K943200
- Applicant / Sponsor: Advance Medical Device, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1540
- Decision date: 1995-11-21
Classification & Regulation
This clearance is catalogued under FDA product code JAF and 21 CFR 892.1540, within the Radiology review panel as a Class II device.