Clearance Summary
CADD Yellow High Volume Administration Set with NRFit connector received FDA 510(k) clearance under submission number K172592, sponsored by Smiths Medical Asd, 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 2018-05-17.
- Submission: K172592
- Applicant / Sponsor: Smiths Medical Asd, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2018-05-17
Classification & Regulation
This clearance is catalogued under FDA product code PWH and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.