VIAL2BAG
FDA 510(k) K072759 · Medimop Medical Projects, Ltd.
510(k) numberK072759
Submission
- Device name
- VIAL2BAG
- Applicant
- Medimop Medical Projects, Ltd.
Lionville, PA, US - Received
- September 28, 2007
- Decision date
- December 13, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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More from Sfm Medical Devices GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K160503 | Vented Vial Adapter Transfer Device - 13mmLHI · Special | 05/04/2016SE |
| K140730 | VIAL2BAG Direct ConnectLHI · Traditional | 06/12/2014SE |
| K130179 | MP Vial Adapter 13MMLHI · Traditional | 08/08/2013SE |
| K132040 | Vial Connector 13MM Closed CollarLHI · Special | 07/31/2013SE |
| K122023 | Mixject with Spray HeadFMF · Traditional | 10/04/2012SE |
| K072511 | Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMLHI · Abbreviated | 12/13/2007SE |
| K062482 | Vented Vial Adapter Transfer DeviceLHI · Traditional | 11/03/2006SE |
| K031861 | MIX2VIAL Transfer DeviceLHI · Traditional | 07/29/2003SE |
| K001831 | Needleless Transfer DeviceLHI · Traditional | 07/11/2000SE |
| K001293 | Modification to Mixject Dispensing Pin/With Detachable Vial Holder/With Detachable Vial…LHI · Special | 05/05/2000SE |
Questions and answers
When was VIAL2BAG cleared by the FDA?
VIAL2BAG (K072759) received a 510(k) decision of Substantially Equivalent on December 13, 2007, 76 days after the submission was received.
What is the product code of K072759?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.