Clearance Summary
VORTEX EZ VASCULAR ACCESS PORT received FDA 510(k) clearance under submission number K050176, sponsored by Rita Medical 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 2005-02-25.
- Submission: K050176
- Applicant / Sponsor: Rita Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 2005-02-25
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.