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FDA 510(k)

Drivewire 35 Guidewire

K-Number: K254006 · 2026-07-17

ApplicantRapid Medical Ltd.
Decision Date2026-07-17
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Drivewire 35 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 2026-07-17 under 510(k) number K254006. 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 Drivewire 35 Guidewire?

Drivewire 35 Guidewire is a medical device that received FDA 510(k) clearance on 2026-07-17. The listed applicant is Rapid Medical Ltd.. The 510(k) number is K254006.

When did Drivewire 35 Guidewire receive FDA 510(k) clearance?

Drivewire 35 Guidewire received FDA 510(k) clearance on 2026-07-17, under 510(k) number K254006.

Who is the listed applicant for Drivewire 35 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 Drivewire 35 Guidewire?

The FDA product code for Drivewire 35 Guidewire is MOF.

Other records listing Rapid Medical Ltd. as applicant

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K253062Tigertriever 25 Revascularization DeviceK251603Tigertriever 17 Ultra Revascularization DeviceK233791Drivewire 24 GuidewireK230429Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization DeviceK220808Tigertriever 13 Revascularization DeviceK203592Tigertriever and Tigertriever 17 Revascularization Devce

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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.

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, LLCK252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.K260130Willow 18 GuidewireArbor Endovascular, LLCK252011CHIKAI Nexus petitAsahi Intecc Co., Ltd.

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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