The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Agility 10 Standard & Soft 0.01in. X 195cm, Agility 14 Standard & Soft 0.014in X 205cm & Xl 350cm, Agility 16 Standard &.
| Device ID | K133625 |
| 510k Number | K133625 |
| Device Name: | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Hannah Foley |
| Correspondent | Hannah Foley Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2014-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704029106 | K133625 | 000 |
| 10886704028383 | K133625 | 000 |
| 10886704028390 | K133625 | 000 |
| 10886704028406 | K133625 | 000 |
| 10886704029038 | K133625 | 000 |
| 10886704029045 | K133625 | 000 |
| 10886704029052 | K133625 | 000 |
| 10886704029069 | K133625 | 000 |
| 10886704029076 | K133625 | 000 |
| 10886704029083 | K133625 | 000 |
| 10886704029090 | K133625 | 000 |
| 10886704028376 | K133625 | 000 |