Clearance Summary
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP received FDA 510(k) clearance under submission number K091921, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2009-09-08.
- Submission: K091921
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5200
- Decision date: 2009-09-08
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.