Clearance Summary
XPRESSWAY RX CATHETER (6F LD-VERISON) received FDA 510(k) clearance under submission number K121301, sponsored by Kaneka Pharma America, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-07-30.
- Submission: K121301
- Applicant / Sponsor: Kaneka Pharma America, LLC
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2012-07-30
Classification & Regulation
This clearance is catalogued under FDA product code QEZ and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.