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FDA 510(k)

X-Wire Guidewire

K-Number: K244061 · 2025-08-26

ApplicantImperative Care, Inc.
Decision Date2025-08-26
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

X-Wire Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K244061. 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 X-Wire Guidewire?

X-Wire Guidewire is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Imperative Care, Inc.. The 510(k) number is K244061.

When did X-Wire Guidewire receive FDA 510(k) clearance?

X-Wire Guidewire received FDA 510(k) clearance on 2025-08-26, under 510(k) number K244061.

Who is the listed applicant for X-Wire Guidewire?

The FDA 510(k) record lists Imperative Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-Wire Guidewire?

The FDA product code for X-Wire Guidewire is MOF.

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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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