FDA.reportPublic FDA data

510(k) K243938

Device
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
Applicant
Scientia Vascular, Inc.
510(k) number
K243938
Product code
MOF
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-01
Date received
2024-12-20
Regulation
870.1330
Classification name
Guide, Wire, Catheter, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Bret Draper
Address
2460 S. 3270 W. West Valley City UT US 84119 84119

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.2026-04-29
K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited2026-04-16
K260537Willow 24 GuidewireArbor Endovascular, LLC2026-03-19
K252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.2026-03-16
K260130Willow 18 GuidewireArbor Endovascular, LLC2026-02-13
K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd.2026-02-02
K2531680.014” Willow GuidewireArbor Endovascular, LLC2025-11-26
K244061X-Wire GuidewireImperative Care, Inc.2025-08-26
K2437560.014” Willow GuidewireArbor Endovascular, LLC2025-07-17
K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd.2025-04-21
K240871Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd.2024-11-18
K233791Drivewire 24 GuidewireRapid-Medical , Ltd.2024-07-11
K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc.2023-08-01
K222690SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA2023-04-24
K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, LLC2023-03-10