Clearance Summary
NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER received FDA 510(k) clearance under submission number K945909, sponsored by Navarre Biomedical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-06-02.
- Submission: K945909
- Applicant / Sponsor: Navarre Biomedical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 1995-06-02
Classification & Regulation
This clearance is catalogued under FDA product code KRA and 21 CFR 870.1210, within the Cardiovascular review panel as a Class II device.