Cleared Traditional

Pre-Formed Extra Support Guidewire

K211741 · Lake Region Medical · Cardiovascular
Nov 2021
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K211741 is an FDA 510(k) clearance for the Pre-Formed Extra Support Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Lake Region Medical (Chaska, US). The FDA issued a Cleared decision on November 22, 2021, 168 days after receiving the submission on June 7, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K211741 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2021
Decision Date November 22, 2021
Days to Decision 168 days
Submission Type Traditional
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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