Cleared Special

CROSSLEAD 0.014inch

K241702 · Asahi Intecc Co., Ltd. · Cardiovascular
Feb 2025
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K241702 is an FDA 510(k) clearance for the CROSSLEAD 0.014inch, 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 February 6, 2025, 238 days after receiving the submission on June 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K241702 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2024
Decision Date February 06, 2025
Days to Decision 238 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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