Clearance Summary
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS received FDA 510(k) clearance under submission number K081489, sponsored by Peter Lazic GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2008-09-25.
- Submission: K081489
- Applicant / Sponsor: Peter Lazic GmbH
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5200
- Decision date: 2008-09-25
Classification & Regulation
This clearance is catalogued under FDA product code HCH and 21 CFR 882.5200, within the Neurology review panel as a Class II device.