Cleared Special

Lunderquist Extra Stiff Wire Guide

K251596 · William Cook Europe Aps · Cardiovascular
Nov 2025
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K251596 is an FDA 510(k) clearance for the Lunderquist Extra Stiff Wire Guide, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on November 9, 2025, 166 days after receiving the submission on May 27, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K251596 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2025
Decision Date November 09, 2025
Days to Decision 166 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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