Clearance Summary
BD Intraosseous Infusion System received FDA 510(k) clearance under submission number K203193, sponsored by Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. 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 2021-03-04.
- Submission: K203193
- Applicant / Sponsor: Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2021-03-04
Classification & Regulation
This clearance is catalogued under FDA product code MHC and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.