K220258 is an FDA 510(k) clearance for the 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000). This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Avia Vascular (Salt Lake City, US). The FDA issued a Cleared decision on July 14, 2022, 164 days after receiving the submission on January 31, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K220258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2022 |
| Decision Date | July 14, 2022 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| 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 |