Clearance Summary
Introcan Safety 3 Closed IV Catheter received FDA 510(k) clearance under submission number K163358, sponsored by B.Braun Melsungen AG. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-04-28.
- Submission: K163358
- Applicant / Sponsor: B.Braun Melsungen AG
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2017-04-28
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.