ClearanceBrief
Panels › Cardiovascular › Product code DQX · Class 2

Wire, Guide, Catheter

Regulation 870.1330

13510(k)s in 12 months (769 all time)
7recalls in 12 months (258 all time)
224recalls that name a 510(k)
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Top companies in DQX

Company510(k)sRecalls
Cook Incorporated2661
Boston Scientific3442
Argon Medical Devices, Inc.153
Asahi Intecc Co., Ltd.480
Advanced Cardiovascular Systems, Inc.450
Arrow International, Inc.131
Lake Region Mfg., Inc.310
Merit Medical Systems, Inc.229
Scimed Life Systems, Inc.300
Guidant Corp.270
Decided510(k)Device and applicantCode
Oct 16, 2026K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)
Skycade Med Corporation
DQX
Sep 18, 2026K253146Hyperdrive 35 Guidewire
Rapid-Medical , Ltd., IL
DQX
Sep 3, 2026K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
Filmecc Co., Ltd., JP
DQX
Jul 14, 2026K253667Accoat Guide Wire
Sp Medical A/S, DK
DQX
Jul 13, 2026K261640Merit MAK Nitinol/Gold-Tungsten Guide Wire
Merit Medical Ireland , Ltd., IE
DQX
May 22, 2026K254137InQwire Amplatz Guide Wire
Merit Medical Ireland, Ltd., IE
DQX
Mar 20, 2026K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP
FMD Co., Ltd., JP
DQX
Mar 19, 2026K253746Enroute 0.014'' Transcarotid Guidewire
Lake Region Medical, IE
DQX
Mar 6, 2026K253262EmeryGlide™ (EG18008901)
Nano4imaging GmbH, DE
DQX
Jan 31, 2026K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Merit Medical Ireland, Ltd., IE
DQX
Jan 21, 2026K251385InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wi
Merit Medical Ireland, Ltd., IE
DQX
Jan 9, 2026K252674Solo Pace Fusion System (SOLOFUSE1)
Solo Pace, Inc.
DQX
Nov 9, 2025K251596Lunderquist Extra Stiff Wire Guide
William Cook Europe Aps, DK
DQX
Oct 17, 2025K250203SureAx-Guide™
Sureax Medical, LLC
DQX
Oct 3, 2025K250031Amplatzer Guidewire
ABBOTT MEDICAL
DQX
Aug 29, 2025K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hyd
Merit Medical Ireland, Ltd., IE
DQX
Jul 25, 2025K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
ABBOTT MEDICAL
DQX
Jun 13, 2025K250075Medtronic Stedi Extra Support Guidewire
Medtronic, Inc.
DQX
Apr 2, 2025K243733SION blue PLUS
Asahi Intecc Co., Ltd., JP
DQX
Mar 27, 2025K241962Crossloop
Asahi Intecc Co., Ltd., JP
DQX
Mar 5, 2025K242597CROSSLEAD 0.018inch
Asahi Intecc Co., Ltd., JP
DQX
Feb 6, 2025K241702CROSSLEAD 0.014inch
Asahi Intecc Co., Ltd., JP
DQX
Dec 10, 2024K241521Prelude Small O.D. Introducer Guide Wire
Merit Medical Systems, Inc.
DQX
Dec 6, 2024K242824PTFE Guidewire
Lake Region Medical
DQX
Nov 26, 2024K240818R2P Radifocus Glidewire Advantage
Terumo Corporation, JP
DQX
Nov 6, 2024K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
ABBOTT MEDICAL
DQX
Sep 18, 2024K241784Arrow® Nitinol Wire
Teleflex Medical
DQX
Aug 21, 2024K240859Glidewire GT-R
Terumo Corporation, JP
DQX
Aug 14, 2024K241510CROSSLEAD Tracker
Asahi Intecc Co., Ltd., JP
DQX
Jun 21, 2024K240387MINAMO blue; MINAMO viola
Asahi Intecc Co., Ltd., JP
DQX
Jun 13, 2024K240460FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
FMD Co., Ltd., JP
DQX
May 24, 2024K240864PacePro Wire
Opsens, Inc., CA
DQX
May 14, 2024K232662BNLE Hydrophilic Jacketed Peripheral Guidewire
Biomerics Nle
DQX
Oct 28, 2023K230418Mighty Wire Guide Wire
Merit Medical Systems, Inc.
DQX
Oct 24, 2023K232570Steerant™ Super Stiff Guidewire
Medtronic Vascular
DQX
Oct 11, 2023K232578VASSALLO GT 018 G12; VASSALLO GT 018 G30
Filmec Co. , Ltd., JP
DQX
Oct 11, 2023K232574VASSALLO GT Crossing14
Filmec Co. , Ltd., JP
DQX
Jul 20, 2023K230377CROSSLEAD Penetration Peripheral Guide Wire
Asahi Intecc Co., Ltd., JP
DQX
Jul 14, 2023K223791TalWire
Embrace Medical , Ltd., IL
DQX
May 5, 2023K230637Wattson temporary pacing guidewire (2250)
Vascular Solutions, LLC
DQX
Apr 28, 2023K221390BNLE Access Guidewire
Biomerics Nle
DQX
Mar 9, 2023K223432Vassallo GT 018 Hybrid
Filmecc Co., Ltd., JP
DQX
Mar 1, 2023K213898ProTrack Pigtail Wire
Baylis Medical Company, Inc., CA
DQX
Dec 19, 2022K221351Mechanical Guidewire
Baylis Medical Company, Inc., CA
DQX
Oct 26, 2022K222631VASSALLO GT EXT
Filmecc Co., Ltd., JP
DQX
Oct 7, 2022K221575Pre-Formed Blue
Lake Region Medical
DQX
Sep 21, 2022K212615EpiFaith CV
Flat Medical Co., Ltd., TW
DQX
Sep 14, 2022K213854SavvyWire
Opsens, Inc., CA
DQX
Sep 6, 2022K213868ASAHI Gladius Mongo18 PV ES
Asahi Intecc Co., Ltd., JP
DQX
Aug 19, 2022K221917Stent Positioning Assistance System (SPAS)
Seven Sons , Ltd., IL
DQX

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