Cleared Traditional

ASAHI Gladius Mongo18 PV ES

K213868 · Asahi Intecc Co., Ltd. · Cardiovascular
Sep 2022
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K213868 is an FDA 510(k) clearance for the ASAHI Gladius Mongo18 PV ES, 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 September 6, 2022, 270 days after receiving the submission on December 10, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K213868 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2021
Decision Date September 06, 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

Similar Devices — DQX Wire, Guide, Catheter

All 760
EmeryGlide? (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026
Lunderquist Extra Stiff Wire Guide
K251596 · William Cook Europe Aps · Nov 2025
SureAx-Guide?
K250203 · Sureax Medical, LLC · Oct 2025