The following data is part of a premarket notification filed by Velano Vascular with the FDA for Tiva¿.
| Device ID | K152924 |
| 510k Number | K152924 |
| Device Name: | TIVA¿ |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | VELANO VASCULAR 4040 LOCUST ST Philadelphia, PA 19104 |
| Contact | Tiffini Diage |
| Correspondent | Tiffini Diage VELANO VASCULAR 4040 LOCUST ST Philadelphia, PA 19104 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-05 |
| Decision Date | 2016-01-07 |
| Summary: | summary |