K163508 is an FDA 510(k) clearance for the PIVO. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Velano Vascular (San Francisco, US). The FDA issued a Cleared decision on February 9, 2017, 57 days after receiving the submission on December 14, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K163508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2016 |
| Decision Date | February 09, 2017 |
| Days to Decision | 57 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |