Clearance Summary
Vial2Bag Direct Connect received FDA 510(k) clearance under submission number K170095, sponsored by Medimop Medical Project , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-03-08.
- Submission: K170095
- Applicant / Sponsor: Medimop Medical Project , Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2017-03-08
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.