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510(k) K961015

Device
SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
Applicant
SCIMED LIFE SYSTEMS, INC.
510(k) number
K961015
Product code
DQX  
Decision
Substantially Equivalent (SESE)
Decision date
1996-05-15
Date received
1996-03-13
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
CONNIE J DEL TORO
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
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
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

Legacy Summary#

summary

FDA Review#

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