K111485 is an FDA 510(k) clearance for the FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on June 30, 2011, 30 days after receiving the submission on May 31, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K111485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2011 |
| Decision Date | June 30, 2011 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| 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 |