K201415 is an FDA 510(k) clearance for the Vial2Bag Advanced 20mm Admixture Device. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by West Pharmaceutical Services Az, Inc. (Scottsdale, US). The FDA issued a Cleared decision on October 21, 2020, 145 days after receiving the submission on May 29, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K201415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2020 |
| Decision Date | October 21, 2020 |
| Days to Decision | 145 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 |