Cleared Special

CROSSLEAD 0.018inch

K242597 · Asahi Intecc Co., Ltd. · Cardiovascular
Mar 2025
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K242597 is an FDA 510(k) clearance for the CROSSLEAD 0.018inch, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Asahi Intecc Co., Ltd. (Seto-Shi, JP). The FDA issued a Cleared decision on March 5, 2025, 187 days after receiving the submission on August 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K242597 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2024
Decision Date March 05, 2025
Days to Decision 187 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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