Scientia Vascular
West Valley City, UT, US
SCIENTIA VASCULAR appears in FDA device records in West Valley City, UT. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Scientia Vascular between 2012 and 2026. The busiest year on record is 2023, with 5. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260223 | Aristotle Mini Guidewire | MOF | Substantially Equivalent | |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | NRY | Substantially Equivalent | |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | MOF | Substantially Equivalent | |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | MOF | Substantially Equivalent | |
| K242301 | Socrates 38 Catheter | QJP | Substantially Equivalent | |
| K223913 | Socrates Aspiration System | NRY | Substantially Equivalent | |
| K223560 | Plato 17 Microcatheter | QJP | Substantially Equivalent | |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | MOF | Substantially Equivalent | |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | MOF | Substantially Equivalent | |
| K222437 | Aristotle Colossus Guidewire | MOF | Substantially Equivalent | |
| K210601 | Plato 17 Microcatheter | DQY | Substantially Equivalent | |
| K201760 | Zoom 14 Guidewire | DQX | Substantially Equivalent | |
| K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile | DQX | Substantially Equivalent | |
| K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile | MOF | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K170406 | Plato MICROCATH 27B Microcatheter | DQO | Substantially Equivalent | |
| K143398 | Plato MICROCATH 27B Microcatheter | DQO | Substantially Equivalent | |
| K121734 | PLATO MICROCATH 27 MICROCATHETER | DQO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009546466 | 3009546466 | SCIENTIA VASCULAR | 2460 South 3270 West, West Valley City, UT 84119 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1235-2025 | 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 interventional or diagnostic procedures. | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1234-2025 | 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 ischemic stroke | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1249-2023 | Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090 | Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain