Clearance Summary
BULLETT PERIPHERAL INFUSION CATHETER received FDA 510(k) clearance under submission number K931027, sponsored by Cardio-Dynamics, Inc.. 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 1994-02-04.
- Submission: K931027
- Applicant / Sponsor: Cardio-Dynamics, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1994-02-04
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.