FDA.report

510(k) K253579

Device
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire
Applicant
Scientia Vascular, Inc.
510(k) number
K253579
Product code
MOF
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-29
Date received
2025-11-17
Regulation
870.1330
Classification name
Guide, Wire, Catheter, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Max Alfonso
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)DeviceApplicantDecision date
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
K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus GuidewireScientia Vascular, Inc.2025-04-01
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