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Scientia Vascular, LLC

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories4
Latest FDA decision2023-03-10
TypeNumberDevice NameCodeDateActions
510(k) K220398 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 GuidewireMOF2023-03-10 View
510(k) K210601 Plato 17 MicrocatheterDQY2021-04-28 View
510(k) K201760 Zoom 14 GuidewireDQX2020-07-29 View
510(k) K192783 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support ProfileDQX2019-10-30 View
510(k) K183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support ProfileMOF2019-03-22 View
510(k) K181828 Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard ProfileMOF2018-08-07 View
510(k) K173235 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support ProfileDQX2018-01-22 View
510(k) K170406 Plato MICROCATH 27B MicrocatheterDQO2017-04-18 View