Vial2Bag Direct Connect— 510(k) K170095
Substantially EquivalentMedimop Medical Project , Ltd.
FDA 510(k) clearance K170095 for Vial2Bag Direct Connect, Substantially Equivalent on 2017-03-08. Applicant: Medimop Medical Project , Ltd.. Device class: 2.
Clearance details
- Applicant
- Medimop Medical Project , Ltd.
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ra'Anana, IL
Recent devices under product code LHI
view allMore clearances from Medimop Medical Project , Ltd.
view allAdverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K170095
K-number listed on FDA's recall record- Z-0767-2019 — Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
- Z-0769-2019 — Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
- Z-0972-2018 — 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 treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170095.
Data sourced from openFDA. This site is unofficial and independent of the FDA.