FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIVO
K Number: K190604
·
Decision May 13, 2019
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
6
Review Days
66
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Basic Information
- Device Name
- PIVO
- K Number
- K190604
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Velano Vascular
- Date Received
- March 8, 2019
- Decision Date
- May 13, 2019
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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Other Clearances by Velano Vascular
| K Number | Device Name | ||
|---|---|---|---|
| K200439 | Velano ExT Extension Set | Feb 23, 2021 | Substantially Equivalent |
| K193569 | PIVO(TM) | Jan 21, 2020 | Substantially Equivalent |
| K182897 | Velano Vascular Q2 Extension Set | Mar 26, 2019 | Substantially Equivalent |
| K163508 | PIVO | Feb 9, 2017 | Substantially Equivalent |
| K152924 | TIVA¿ | Jan 7, 2016 | Substantially Equivalent |