The following data is part of a premarket notification filed by Innovamed Health, Llc with the FDA for Vena Pro.
| Device ID | K133274 |
| 510k Number | K133274 |
| Device Name: | VENA PRO |
| Classification | Sleeve, Limb, Compressible |
| Applicant | INNOVAMED HEALTH, LLC 2839 HARVEST MOON DRIVE Orange Park, FL 32073 |
| Contact | Joe Adkins |
| Correspondent | Joe Adkins INNOVAMED HEALTH, LLC 2839 HARVEST MOON DRIVE Orange Park, FL 32073 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-24 |
| Decision Date | 2014-02-12 |
| Summary: | summary |