Clearance Summary
VASCUTEK VASCULAR PROTHESIS VP1200K/50K received FDA 510(k) clearance under submission number K830016, sponsored by Pacesetter Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1983-12-21.
- Submission: K830016
- Applicant / Sponsor: Pacesetter Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 1983-12-21
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.