Clearance Summary
PARADIGM QUICK-SET INFUSION SET received FDA 510(k) clearance under submission number K011071, sponsored by Maersk Medical A/S. 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 2001-06-07.
- Submission: K011071
- Applicant / Sponsor: Maersk Medical A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2001-06-07
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.