The following data is part of a premarket notification filed by Velano Vascular with the FDA for Pivo(tm).
| Device ID | K193569 |
| 510k Number | K193569 |
| Device Name: | PIVO(TM) |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Velano Vascular 221 Pine St #200 San Francisco, CA 94104 |
| Contact | Tiffini Wittwer |
| Correspondent | Tiffini Wittwer Velano Vascular 221 Pine St #200 San Francisco, CA 94104 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-01-21 |