Cleared Special

Lunderquist Extra Stiff Wire Guide

K220137 · William Cook Europe Aps · Cardiovascular
Feb 2022
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K220137 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 February 17, 2022, 30 days after receiving the submission on January 18, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K220137 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2022
Decision Date February 17, 2022
Days to Decision 30 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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