Clearance Summary
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology received FDA 510(k) clearance under submission number K181563, sponsored by Access Scientific, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-09-26.
- Submission: K181563
- Applicant / Sponsor: Access Scientific, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2018-09-26
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.