Cleared Special

CROSSLEAD Penetration Peripheral Guide Wire

K230377 · Asahi Intecc Co., Ltd. · Cardiovascular
Jul 2023
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K230377 is an FDA 510(k) clearance for the CROSSLEAD Penetration Peripheral Guide Wire, 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 July 20, 2023, 157 days after receiving the submission on February 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K230377 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2023
Decision Date July 20, 2023
Days to Decision 157 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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