Cleared Special

CROSSLEAD Tracker

K241510 · Asahi Intecc Co., Ltd. · Cardiovascular
Aug 2024
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K241510 is an FDA 510(k) clearance for the CROSSLEAD Tracker, 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 August 14, 2024, 77 days after receiving the submission on May 29, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K241510 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2024
Decision Date August 14, 2024
Days to Decision 77 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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