Clearance Summary
POLYFIN EXTENSION SET, MODELS 126 AND 128 received FDA 510(k) clearance under submission number K965208, 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 1997-02-26.
- Submission: K965208
- Applicant / Sponsor: Medtronic Minimed
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1997-02-26
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.