K122265 is an FDA 510(k) clearance for the VIALOK SINGLE VIAL ACCESS DEVICE VENTED. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Yukon Medical, LLC (Durham, US). The FDA issued a Cleared decision on August 14, 2012, 15 days after receiving the submission on July 30, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K122265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2012 |
| Decision Date | August 14, 2012 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |