Clearance Summary
BRAIDED HIGH PRESSURE CATHETER CONNECTOR received FDA 510(k) clearance under submission number K905415, sponsored by The R Group. 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 1991-08-12.
- Submission: K905415
- Applicant / Sponsor: The R Group
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1991-08-12
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.