Clearance Summary
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile received FDA 510(k) clearance under submission number K183608, sponsored by Scientia Vascular, 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 2019-03-22.
- Submission: K183608
- Applicant / Sponsor: Scientia Vascular, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2019-03-22
Classification & Regulation
This clearance is catalogued under FDA product code MOF and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.