Cleared Special

PTFE Guidewire

K242824 · Lake Region Medical · Cardiovascular
Dec 2024
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K242824 is an FDA 510(k) clearance for the PTFE 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 December 6, 2024, 79 days after receiving the submission on September 18, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K242824 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2024
Decision Date December 06, 2024
Days to Decision 79 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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