Clearance Summary
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & received FDA 510(k) clearance under submission number K133625, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-02-24.
- Submission: K133625
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2014-02-24
Classification & Regulation
This clearance is catalogued under FDA product code MOF and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.