Clearance Summary
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 received FDA 510(k) clearance under submission number K073200, sponsored by Vascular Solutions, 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 2008-02-01.
- Submission: K073200
- Applicant / Sponsor: Vascular Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2008-02-01
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.