K180389 is an FDA 510(k) clearance for the Venera 508 Deep Vein Thrombosis (DVT) Prevention System. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on June 29, 2018, 136 days after receiving the submission on February 13, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K180389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2018 |
| Decision Date | June 29, 2018 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |