Cleared Traditional

Crossloop

K241962 · Asahi Intecc Co., Ltd. · Cardiovascular
Mar 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K241962 is an FDA 510(k) clearance for the Crossloop, 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 27, 2025, 267 days after receiving the submission on July 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K241962 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2024
Decision Date March 27, 2025
Days to Decision 267 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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