FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Vial2Bag Advanced® 13mm Admixture Device
K Number: K230988
·
Decision Dec 1, 2023
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
5
Review Days
239
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Vial2Bag Advanced® 13mm Admixture Device
- K Number
- K230988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- West Pharma. Services IL, Ltd.
- Date Received
- April 6, 2023
- Decision Date
- December 1, 2023
- Product Code
- LHI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHI), ordered by most recent decision date.
ADRx Admixture Device
FDA 510(k)
FDA Class 2
·General Hospital
Vial Adapter
FDA 510(k)
FDA Class 2
·General Hospital
Medline Bag Decanter
FDA 510(k)
FDA Class 2
·General Hospital
FlowArt® Vial Access Device Vented
FDA 510(k)
FDA Class 2
·General Hospital
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
FDA 510(k)
FDA Class 2
·General Hospital
HyHub and HyHub Duo Vial Access Devices
FDA 510(k)
FDA Class 2
·General Hospital