Cleared Traditional

X-Wire Guidewire

K244061 · Imperative Care, Inc. · Neurology
Aug 2025
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K244061 is an FDA 510(k) clearance for the X-Wire Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on August 26, 2025, 238 days after receiving the submission on December 31, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K244061 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2024
Decision Date August 26, 2025
Days to Decision 238 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MOF — Guide, Wire, Catheter, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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