Vial2Bag Direct Connect
FDA 510(k) clearance K170095 · decided 2017-03-08
Clearance details
- K-number
- K170095
- Device name
- Vial2Bag Direct Connect
- Applicant
- Medimop Medical Project , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-11
- Decision date
- 2017-03-08
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ra'Anana, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only recall (Z-0767-2019) | WEST PHARMA. SERVICES IL, LTD | 2019-01-28 |
| Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only recall (Z-0769-2019) | WEST PHARMA. SERVICES IL, LTD | 2019-01-28 |