K180726 is an FDA 510(k) clearance for the Savion DLVR Guidewire, Savion FLX Guidewire. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Boston Scientific, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 18, 2018, 90 days after receiving the submission on March 20, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K180726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2018 |
| Decision Date | June 18, 2018 |
| Days to Decision | 90 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 |