K143587 is an FDA 510(k) clearance for the ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire. 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 January 15, 2015, 28 days after receiving the submission on December 18, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K143587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2014 |
| Decision Date | January 15, 2015 |
| Days to Decision | 28 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 |