Clearance Summary
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 received FDA 510(k) clearance under submission number K974163, sponsored by Medtronic Minimed. 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 1998-02-02.
- Submission: K974163
- Applicant / Sponsor: Medtronic Minimed
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1998-02-02
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.