K153685 is an FDA 510(k) clearance for the Sunmed Haemostatic Valves. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Sunny Medical Device (Shenzhen) Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on October 13, 2016, 296 days after receiving the submission on December 22, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K153685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2015 |
| Decision Date | October 13, 2016 |
| Days to Decision | 296 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 |