K133625 is an FDA 510(k) clearance for the AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on February 24, 2014, 90 days after receiving the submission on November 26, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K133625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2013 |
| Decision Date | February 24, 2014 |
| Days to Decision | 90 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MOF - Guide, Wire, Catheter, Neurovasculature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |