K193653 is an FDA 510(k) clearance for the Hydrophilic Coating Guide Wire. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Suzhou Hengrui Disheng Medical Co., Ltd. (Suzhou 215163, CN). The FDA issued a Cleared decision on August 26, 2020, 240 days after receiving the submission on December 30, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K193653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2019 |
| Decision Date | August 26, 2020 |
| Days to Decision | 240 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 |