Cleared Traditional

Arrow? Nitinol Wire

K241784 · Teleflex Medical · Cardiovascular
Sep 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K241784 is an FDA 510(k) clearance for the Arrow? Nitinol Wire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on September 18, 2024, 90 days after receiving the submission on June 20, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K241784 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2024
Decision Date September 18, 2024
Days to Decision 90 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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