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Scientia Vascular, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
16
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1235-2025Class IIPlato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolizaJanuary 16, 2025
Z-1234-2025Class IISocrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System wJanuary 2, 2025
Z-1249-2023Class IIPlato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL1February 1, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; ArisApril 1, 2025
K242301Socrates 38 CatheterDecember 4, 2024
K223913Socrates Aspiration SystemSeptember 20, 2023
K223560Plato 17 MicrocatheterAugust 21, 2023
K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireAugust 1, 2023
K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom WireMarch 10, 2023
K222437Aristotle Colossus GuidewireJanuary 26, 2023
K210601Plato 17 MicrocatheterApril 28, 2021
K201760Zoom 14 GuidewireJuly 29, 2020
K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; ArisOctober 30, 2019
K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; ArisMarch 22, 2019
K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 GuidewirAugust 7, 2018
K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, AristotJanuary 22, 2018
K170406Plato MICROCATH 27B MicrocatheterApril 18, 2017
K143398Plato MICROCATH 27B MicrocatheterJune 26, 2015
K121734PLATO MICROCATH 27 MICROCATHETERJuly 30, 2012