Cleared Traditional

Asahi PTCA Guide Wire Asahi SION Series

K191464 · Asahi Intecc Co., Ltd. · Cardiovascular
Nov 2019
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K191464 is an FDA 510(k) clearance for the Asahi PTCA Guide Wire Asahi SION Series, 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 November 21, 2019, 171 days after receiving the submission on June 3, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K191464 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2019
Decision Date November 21, 2019
Days to Decision 171 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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