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FDA 510(k)

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire

K-Number: K220398 · 2023-03-10

ApplicantScientia Vascular, LLC
Decision Date2023-03-10
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is a medical device manufactured by Scientia Vascular, LLC. It received FDA 510(k) clearance on 2023-03-10 under approval number K220398. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is a medical device that received FDA 510(k) clearance on 2023-03-10. It is manufactured by Scientia Vascular, LLC. The 510(k) number is K220398.

When was Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire approved by the FDA?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire received FDA 510(k) clearance on 2023-03-10, under approval number K220398.

What company makes Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is manufactured by Scientia Vascular, LLC.

What is the FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

The FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is MOF.

Other Devices by Scientia Vascular, LLC

K170406Plato MICROCATH 27B Microcatheter K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile K201760Zoom 14 Guidewire

View all 8 devices →

Related Devices (Code: MOF)

K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc. K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipAsahi Intecc Co., Ltd. K161803Traxcess .007 Mini GuidewireMicroVention, Inc. K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)Asahi Intecc Co., Ltd. K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd. K182337HYBRID GuidewireBalt USA, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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