K213513 is an FDA 510(k) clearance for the Vented Vial Adapter 20mm. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by West Pharma Services Il, Ltd. (Ra'Anana Central, IL). The FDA issued a Cleared decision on August 31, 2022, 302 days after receiving the submission on November 2, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K213513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2021 |
| Decision Date | August 31, 2022 |
| Days to Decision | 302 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 |