510(k) K170095 ยท LHI Set, I.V. Fluid Transfer
Vial2Bag Direct Connect
| Applicant | Medimop Medical Project , Ltd., Ra'Anana, IL |
| Decision | Substantially Equivalent, Mar 8, 2017 |
| Received | Jan 11, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2019 | WEST PHARMA. SERVICES IL, LTD Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only Terminated |
LHI | None listed |
| Jan 28, 2019 | WEST PHARMA. SERVICES IL, LTD Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only Terminated |
LHI | None listed |
| Oct 6, 2017 | Medimop Medical Projects Ltd. Vial2BagDC, Product Number 6070112.
The 20mm Vial2Bag DC device, is intended for use in
healthcare facilities or in-home environment by the patient
or care-giver to aid and support prescribed treatme Terminated |
LHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.