K031916 is an FDA 510(k) clearance for the GALT MEDICAL GUIDEWIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on July 17, 2003, 27 days after receiving the submission on June 20, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K031916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2003 |
| Decision Date | July 17, 2003 |
| Days to Decision | 27 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 |