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FDA 510(k)

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile

K-Number: K181828 · 2018-08-07

ApplicantScientia Vascular, LLC
Decision Date2018-08-07
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, LLC. It received FDA 510(k) clearance on 2018-08-07 under 510(k) number K181828. 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 Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile?

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile is a medical device that received FDA 510(k) clearance on 2018-08-07. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K181828.

When did Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile receive FDA 510(k) clearance?

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile received FDA 510(k) clearance on 2018-08-07, under 510(k) number K181828.

Who is the listed applicant for Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile?

The FDA 510(k) record lists Scientia Vascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile?

The FDA product code for Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile is MOF.

Other records listing Scientia Vascular, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260223Aristotle Mini GuidewireK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireK243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus GuidewireK242301Socrates 38 CatheterK223913Socrates Aspiration System

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Related Devices (Code: MOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262424Willow 12 GuidewireArbor Endovascular, LLCK260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech LimitedK260537Willow 24 GuidewireArbor Endovascular, 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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