FDA.report

510(k) K250203

Device
SureAx-Guide™
Applicant
Sureax Medical, LLC
510(k) number
K250203
Product code
DQX
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-17
Date received
2025-01-24
Regulation
870.1330
Classification name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ricardo Villanueva
Address
11107 Roselle St. Suite 237 San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code DQX

510(k)DeviceApplicantDecision date
K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.2026-03-20
K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical2026-03-19
K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH2026-03-06
K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd.2026-01-31
K251385InQwire 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)Merit Medical Ireland, Ltd.2026-01-21
K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.2026-01-09
K251596Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps2025-11-09
K250031Amplatzer GuidewireABBOTT MEDICAL2025-10-03
K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)Merit Medical Ireland, Ltd.2025-08-29
K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireABBOTT MEDICAL2025-07-25
K250075Medtronic Stedi Extra Support GuidewireMedtronic, Inc.2025-06-13
K243733SION blue PLUSAsahi Intecc Co., Ltd.2025-04-02
K241962CrossloopAsahi Intecc Co., Ltd.2025-03-27
K242597CROSSLEAD 0.018inchAsahi Intecc Co., Ltd.2025-03-05
K241702CROSSLEAD 0.014inchAsahi Intecc Co., Ltd.2025-02-06