Clearance Summary
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set received FDA 510(k) clearance under submission number K201142, sponsored by Simplivia Healthcare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-02-25.
- Submission: K201142
- Applicant / Sponsor: Simplivia Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2021-02-25
Classification & Regulation
This clearance is catalogued under FDA product code ONB and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.