Clearance Summary
VASCULAR ARCHITECTS PERISCOPE DEVICE received FDA 510(k) clearance under submission number K003719, sponsored by Vascular Architects, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-02-28.
- Submission: K003719
- Applicant / Sponsor: Vascular Architects, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 2001-02-28
Classification & Regulation
This clearance is catalogued under FDA product code DWX and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.