Cleared Special

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

K211898 · Asahi Intecc Co., Ltd. · Cardiovascular
Dec 2021
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K211898 is an FDA 510(k) clearance for the ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20, 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 December 8, 2021, 170 days after receiving the submission on June 21, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K211898 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2021
Decision Date December 08, 2021
Days to Decision 170 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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