Clearance Summary
67-8006 DARLING-LINTON AORTIC TOURN. received FDA 510(k) clearance under submission number K761161, sponsored by Codman & Shurtleff, 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 1976-12-06.
- Submission: K761161
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1976-12-06
Classification & Regulation
This clearance is catalogued under FDA product code DWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.