Cleared Special

ASAHI PTCA Guide Wire ASAHI Gaia Next

K192599 · Asahi Intecc Co., Ltd. · Cardiovascular
Jan 2020
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K192599 is an FDA 510(k) clearance for the ASAHI PTCA Guide Wire ASAHI Gaia Next, 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 January 2, 2020, 104 days after receiving the submission on September 20, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K192599 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2019
Decision Date January 02, 2020
Days to Decision 104 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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