Cleared Traditional

CROSSLEAD Peripheral Guide Wire

K213315 · Asahi Intecc Co., Ltd. · Cardiovascular
Jul 2022
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K213315 is an FDA 510(k) clearance for the CROSSLEAD 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 1, 2022, 270 days after receiving the submission on October 4, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K213315 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2021
Decision Date July 01, 2022
Days to Decision 270 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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