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Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Prof — Scientia Vascular, LLC (510(k) K19278

Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Prof — Scientia Vascular, LLC (510(k) K19278 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Prof; Applican

Device nameAristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Prof
ApplicantScientia Vascular, LLC
Clearance track510(k)
Submission numberK192783
DecisionSubstantially Equivalent
Decision date2019-10-30
Date received2019-09-30
Product codeDQX
Device class2
Medical specialtyCardiovascular
Applicant locationUT, US
SourceopenFDA device

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