Velano Vascular
FDA Regulatory Profile
Velano Vascular appears in FDA public data with 1 recall, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0527-2022, Class II) was initiated on November 10, 2021. Its most recent 510(k) clearance was granted on October 3, 2022.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0527-2022 | Class II | PIVO Blood Collection Device 20G, REF: 202-0005 | November 10, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201237 | Velano Vascular Blood Collection Adapter | October 3, 2022 |
| K200439 | Velano ExT Extension Set | February 23, 2021 |
| K193569 | PIVO(TM) | January 21, 2020 |
| K190604 | PIVO | May 13, 2019 |
| K182897 | Velano Vascular Q2 Extension Set | March 26, 2019 |
| K163508 | PIVO | February 9, 2017 |
| K152924 | TIVA¿ | January 7, 2016 |
| K142946 | TIVA | January 8, 2015 |