510(k) K133625
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & by
Codman & Shurtleff, Inc.
— Product Code MOF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2014
- Date Received
- November 26, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Guide, Wire, Catheter, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- NE
- Submission Type