Clearance Summary
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS received FDA 510(k) clearance under submission number K002007, sponsored by Sulzer Carbomedics, 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 2001-01-25.
- Submission: K002007
- Applicant / Sponsor: Sulzer Carbomedics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2001-01-25
Classification & Regulation
This clearance is catalogued under FDA product code DSY and 21 CFR 870.3450, within the Cardiovascular review panel as a Class II device.