X-Wire Guidewire

FDA 510(k) K244061 · Imperative Care, Inc.

Substantially Equivalent

510(k) numberK244061

Submission

Device name
X-Wire Guidewire
Applicant
Imperative Care, Inc.
Campbell, CA, US
Received
December 31, 2024
Decision date
August 26, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MOF – Guide, Wire, Catheter, Neurovasculature
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1330
Specialty
Cardiovascular

Other 510(k)s with product code MOF

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K254006Drivewire 35 GuidewireMOF · Traditional Rapid Medical Ltd.07/17/2026SE
K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional Scientia Vascular, Inc.04/29/2026SE
K252317Zenith Micro GuidewireMOF · Traditional Suzhou Zenith Vascular SciTech Limited04/16/2026SE
K260537Willow 24 GuidewireMOF · Special Arbor Endovascular, LLC03/19/2026SE
K252122DCwire Micro-guidewireMOF · Traditional Shanghai Achieva Medical Suzhou Co., Ltd.03/16/2026SE
K260130Willow 18 GuidewireMOF · Special Arbor Endovascular, LLC02/13/2026SE
K252011CHIKAI Nexus petitMOF · Traditional Asahi Intecc Co., Ltd.02/02/2026SE

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K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemQEW · Special 05/14/2025SE
K242672Zoom SystemNRY · Traditional 01/14/2025SE
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K233975Zoom 6F Insert CathetersDQO · Traditional 04/02/2024SE
K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Special 05/22/2023SE
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Questions and answers

When was X-Wire Guidewire cleared by the FDA?

X-Wire Guidewire (K244061) received a 510(k) decision of Substantially Equivalent on August 26, 2025, 238 days after the submission was received.

What is the product code of K244061?

The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.