Clearance Summary
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor received FDA 510(k) clearance under submission number K180574, sponsored by J & J Solutions, Inc. D/B/A/ Corvida Medical. 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 2018-08-17.
- Submission: K180574
- Applicant / Sponsor: J & J Solutions, Inc. D/B/A/ Corvida Medical
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2018-08-17
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.