Total clearances
3
2020-01-21 → 2022-10-03
Name variants in FDA filings: Velano Vascular / Velano Vascular
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| JKA |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Class II |
Clinical Chemistry |
2 |
2022-10-03 |
| FPA |
— |
— |
— |
1 |
2021-02-23 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2021-11-10 |
Class II
|
Terminated |
Z-0527-2022 |
PIVO Blood Collection Device 20G, REF: 202-0005 |
— |
Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial cont… |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2022-10-03 |
K201237 |
Velano Vascular Blood Collection Adapter |
JKA |
Class II |
Clinical Chemistry |
| 2021-02-23 |
K200439 |
Velano ExT Extension Set |
FPA |
— |
— |
| 2020-01-21 |
K193569 |
PIVO(TM) |
JKA |
Class II |
Clinical Chemistry |