Clearance Summary
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology received FDA 510(k) clearance under submission number K180548, sponsored by C.R. Bard, Inc (Bard Has Joined Bd). 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 2018-04-26.
- Submission: K180548
- Applicant / Sponsor: C.R. Bard, Inc (Bard Has Joined Bd)
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2018-04-26
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.