Company ยท US
Scientia Vascular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (4 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2026 | K254181 | Aristotle 65 Macrowire Scientia Vascular | MOF |
| Aug 6, 2026 | K260223 | Aristotle Mini Guidewire Scientia Vascular, Inc. | MOF |
| Jul 16, 2026 | K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) Scientia Vascular, Inc. | NRY |
| Apr 29, 2026 | K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire Scientia Vascular, Inc. | MOF |
| Apr 1, 2025 | K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guide Scientia Vascular, Inc. | MOF |
| Dec 4, 2024 | K242301 | Socrates 38 Catheter Scientia Vascular, Inc. | QJP |
| Sep 20, 2023 | K223913 | Socrates Aspiration System Scientia Vascular, Inc. | NRY |
| Aug 21, 2023 | K223560 | Plato 17 Microcatheter Scientia Vascular, Inc. | QJP |
| Aug 1, 2023 | K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire Scientia Vascular, Inc. | MOF |
| Mar 10, 2023 | K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire Scientia Vascular, LLC | MOF |
| Jan 26, 2023 | K222437 | Aristotle Colossus Guidewire Scientia Vascular, Inc. | MOF |
| Apr 28, 2021 | K210601 | Plato 17 Microcatheter Scientia Vascular, LLC | DQY |
| Jul 29, 2020 | K201760 | Zoom 14 Guidewire Scientia Vascular, LLC | DQX |
| Oct 30, 2019 | K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, Scientia Vascular, LLC | DQX |
| Mar 22, 2019 | K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, Scientia Vascular, LLC | MOF |
| Aug 7, 2018 | K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profi Scientia Vascular, LLC | MOF |
| Jan 22, 2018 | K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300 Scientia Vascular, LLC | DQX |
| Apr 18, 2017 | K170406 | Plato MICROCATH 27B Microcatheter Scientia Vascular, LLC | DQO |
| Jun 26, 2015 | K143398 | Plato MICROCATH 27B Microcatheter Scientia Vascular, LLC | DQO |
| Jul 30, 2012 | K121734 | PLATO MICROCATH 27 MICROCATHETER Scientia Vascular, LLC | DQO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2025 | Scientia Vascular, Inc. Plato 17 Microcatheter REF PL17-160-090
To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interv Open, Classified |
QJP | K223560 |
| Feb 26, 2025 | Scientia Vascular, Inc. Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001
The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute isch Open, Classified |
NRY | K223913 |
| Mar 13, 2023 | Scientia Vascular, Inc. Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090 Open, Classified |
DQY | K210601 |