Velano Vascular
Medical device manufacturer in San Francisco, CA.
8510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K201237 | Velano Vascular Blood Collection AdapterJKA · Traditional | 10/03/2022SE |
| K200439 | Velano ExT Extension SetFPA · Traditional | 02/23/2021SE |
| K193569 | Pivo(Tm)JKA · Special | 01/21/2020SE |
| K190604 | PivoJKA · Special | 05/13/2019SE |
| K182897 | Velano Vascular Q2 Extension SetFPA · Traditional | 03/26/2019SE |
| K163508 | PivoJKA · Special | 02/09/2017SE |
| K152924 | Tiva¿JKA · Traditional | 01/07/2016SE |
| K142946 | TivaJKA · Traditional | 01/08/2015SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0527-2022 Class II | PIVO Blood Collection Device 20G, REF: 202-0005Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier… | 11/10/2021Terminated |