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510(k) K151840

Device
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
Applicant
Boston Scientific Corporation
510(k) number
K151840
Product code
DQX  
Decision
Substantially Equivalent (SESE)
Decision date
2015-12-16
Date received
2015-07-06
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
No

Applicant Contact#

Contact
Nikki M Wahlberg
Address
One Scimed Pl. Maple Grove MN US 55311 55311

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.2026-09-18
K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.2026-09-03
K253667Accoat Guide WireSp Medical A/S2026-07-14
K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.2026-07-13
K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.2026-05-22
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
K250203SureAx-Guide™Sureax Medical, LLC2025-10-17
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

Legacy Summary#

summary

FDA Review#

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