Clearance Summary
PROFLEX 5 received FDA 510(k) clearance under submission number K915168, sponsored by Peripheral Systems Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1992-02-19.
- Submission: K915168
- Applicant / Sponsor: Peripheral Systems Group
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1992-02-19
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.