Clearance Summary
EZ-IO Intraosseous Vascular Access System received FDA 510(k) clearance under submission number K180395, sponsored by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). 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 2018-11-09.
- Submission: K180395
- Applicant / Sponsor: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2018-11-09
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.