Data / Medical devices / United States / Scientia Vascular

Scientia Vascular: FDA-registered device maker in West Valley City, UT, United States, 13 510(k) clearances

Name: Scientia Vascular FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Scientia Vascular is registered with the FDA (registration 3009546466) in West Valley City, UT, United States. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 6, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009546466
Address: 2460 South 3270 West, West Valley City, UT, United States, 84119
Owner or operator: Medtronic, Inc. (2112641)
Roles: Manufacturer
First device listed: July 8, 2026
Registered through: 2026
Brand names listed: Aristotle 14 Guidewire, Aristotle 18 Guidewire, Aristotle 24 Guidewire, Aristotle Colossus Guidewire, Aristotle Mini Guidewire, Plato 17 Microcatheter, Socrates 38 Catheter, Zoom Wire 14 Guidewire

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Manufacturer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Manufacturer	accessdata.fda.gov
Guide, Wire, Catheter, Neurovasculature	MOF	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 6, 2026	K260223	Aristotle Mini Guidewire	MOF	Substantially Equivalent	Scientia Vascular, Inc.	accessdata.fda.gov
April 29, 2026	K253579	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire	MOF	Substantially Equivalent	Scientia Vascular, Inc.	accessdata.fda.gov
April 1, 2025	K243938	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire	MOF	Substantially Equivalent	Scientia Vascular, Inc.	accessdata.fda.gov
December 4, 2024	K242301	Socrates 38 Catheter	QJP	Substantially Equivalent	Scientia Vascular, Inc.	accessdata.fda.gov
September 20, 2023	K223913	Socrates Aspiration System	NRY	Substantially Equivalent	Scientia Vascular, Inc.	accessdata.fda.gov
August 21, 2023	K223560	Plato 17 Microcatheter	QJP	Substantially Equivalent	Scientia Vascular, Inc.	accessdata.fda.gov
August 1, 2023	K231954	Aristotle 18 Guidewire; Aristotle 24 Guidewire	MOF	Substantially Equivalent	Scientia Vascular, Inc.	accessdata.fda.gov
January 26, 2023	K222437	Aristotle Colossus Guidewire	MOF	Substantially Equivalent	Scientia Vascular, Inc.	accessdata.fda.gov
April 28, 2021	K210601	Plato 17 Microcatheter	DQY	Substantially Equivalent	Scientia Vascular, LLC	accessdata.fda.gov
July 29, 2020	K201760	Zoom 14 Guidewire	DQX	Substantially Equivalent	Scientia Vascular, LLC	accessdata.fda.gov
October 30, 2019	K192783	Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile	DQX	Substantially Equivalent	Scientia Vascular, LLC	accessdata.fda.gov
March 22, 2019	K183608	Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile	MOF	Substantially Equivalent	Scientia Vascular, LLC	accessdata.fda.gov
January 22, 2018	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	Scientia Vascular, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 16, 2025	96175	Class II	Ongoing	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 diagnosti	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.	accessdata.fda.gov
January 2, 2025	96158	Class II	Ongoing	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.	accessdata.fda.gov
February 1, 2023	91676	Class II	Ongoing	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 sub	accessdata.fda.gov

Compare with other makers

Updated August 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.