Company · US
Velano Vascular
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2022. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 2022 | K201237 | Velano Vascular Blood Collection Adapter Velano Vascular | JKA |
| Feb 23, 2021 | K200439 | Velano ExT Extension Set Velano Vascular | FPA |
| Jan 21, 2020 | K193569 | PIVO(TM) Velano Vascular | JKA |
| May 13, 2019 | K190604 | PIVO Velano Vascular | JKA |
| Mar 26, 2019 | K182897 | Velano Vascular Q2 Extension Set Velano Vascular | FPA |
| Feb 9, 2017 | K163508 | PIVO Velano Vascular | JKA |
| Jan 7, 2016 | K152924 | TIVA¿ Velano Vascular | JKA |
| Jan 8, 2015 | K142946 | TIVA Velano Vascular, Inc. | JKA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2021 | Velano Vascular PIVO Blood Collection Device 20G, REF: 202-0005 Terminated |
JKA | K193569 |