Clearance Summary
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit received FDA 510(k) clearance under submission number K192289, sponsored by Irras USA, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-11-15.
- Submission: K192289
- Applicant / Sponsor: Irras USA, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 2019-11-15
Classification & Regulation
This clearance is catalogued under FDA product code JXG and 21 CFR 882.5550, within the Neurology review panel as a Class II device.