The following data is part of a premarket notification filed by West Pharmaceutical Services Az, Inc. with the FDA for Vial2bag Advanced 20mm Admixture Device.
| Device ID | K201415 |
| 510k Number | K201415 |
| Device Name: | Vial2Bag Advanced 20mm Admixture Device |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | West Pharmaceutical Services AZ, Inc. 14677 North 74th Street Scottsdale, AZ 85260 |
| Contact | Elena Mack |
| Correspondent | Di Wu West Pharmaceutical Services, Inc. 530 Herman O West Drive Exton, PA 19341 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-29 |
| Decision Date | 2020-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850022888018 | K201415 | 000 |