Clearance Summary
PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports received FDA 510(k) clearance under submission number K242328, sponsored by Bard Access Systems, Inc.. 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 2024-10-31.
- Submission: K242328
- Applicant / Sponsor: Bard Access Systems, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 2024-10-31
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.