The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Agility Steerable Guidewire Neuroscout Steerable Gudiewire.
| Device ID | K121776 |
| 510k Number | K121776 |
| Device Name: | AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Joan Bartle |
| Correspondent | Joan Bartle Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-18 |
| Decision Date | 2012-08-14 |
| Summary: | summary |