K100351 is an FDA 510(k) clearance for the NEUROSCOUT STEERABLE GUIDEWIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on March 16, 2010, 32 days after receiving the submission on February 12, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K100351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2010 |
| Decision Date | March 16, 2010 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |