Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Scientia Vascular, LLC

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

Total Devices8
Categories4
Latest Approval2023-03-10
TypeNumberDevice NameCodeDate
510(k) K220398 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire MOF 2023-03-10 View
510(k) K210601 Plato 17 Microcatheter DQY 2021-04-28 View
510(k) K201760 Zoom 14 Guidewire DQX 2020-07-29 View
510(k) K192783 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile DQX 2019-10-30 View
510(k) K183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile MOF 2019-03-22 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 Profile MOF 2018-08-07 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 Profile DQX 2018-01-22 View
510(k) K170406 Plato MICROCATH 27B Microcatheter DQO 2017-04-18 View