K971688 is an FDA 510(k) clearance for the IVT 0.014 PTFE-COATED TRACKWIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Boston Scientific /International Technologies (San Diego, US). The FDA issued a Cleared decision on December 11, 1997, 218 days after receiving the submission on May 7, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K971688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1997 |
| Decision Date | December 11, 1997 |
| Days to Decision | 218 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 |