Clearance Summary
MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter received FDA 510(k) clearance under submission number K161779, sponsored by Medsource International, LLC. 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 2016-11-03.
- Submission: K161779
- Applicant / Sponsor: Medsource International, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2016-11-03
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.