Cleared Traditional

R2P Radifocus Glidewire Advantage

K240818 · Terumo Corporation · Cardiovascular
Nov 2024
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K240818 is an FDA 510(k) clearance for the R2P Radifocus Glidewire Advantage, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Terumo Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 26, 2024, 246 days after receiving the submission on March 25, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K240818 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2024
Decision Date November 26, 2024
Days to Decision 246 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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