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FDA 510(k)

Columbus Guidewire

K-Number: K200374 · 2020-12-14

ApplicantRapid-Medical , Ltd.
Decision Date2020-12-14
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Columbus Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Rapid-Medical , Ltd.. It received FDA 510(k) clearance on 2020-12-14 under 510(k) number K200374. 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 Columbus Guidewire?

Columbus Guidewire is a medical device that received FDA 510(k) clearance on 2020-12-14. The listed applicant is Rapid-Medical , Ltd.. The 510(k) number is K200374.

When did Columbus Guidewire receive FDA 510(k) clearance?

Columbus Guidewire received FDA 510(k) clearance on 2020-12-14, under 510(k) number K200374.

Who is the listed applicant for Columbus Guidewire?

The FDA 510(k) record lists Rapid-Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Columbus Guidewire?

The FDA product code for Columbus Guidewire is MOF.

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Other records listing Rapid-Medical , Ltd. 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.

K254006Drivewire 35 GuidewireK253062Tigertriever 25 Revascularization DeviceK251603Tigertriever 17 Ultra Revascularization DeviceK233791Drivewire 24 GuidewireK230429Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization DeviceK220808Tigertriever 13 Revascularization Device

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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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