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510(k) K971395

Device
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE
Applicant
TARGET THERAPEUTICS
510(k) number
K971395
Product code
DQX  
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-14
Date received
1997-04-15
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
ROXANE K BAXTER
Address
47201 Lakeview Dr. Freemont CA US 94538 94538

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
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
K243733SION blue PLUSAsahi Intecc Co., Ltd.2025-04-02
K241962CrossloopAsahi Intecc Co., Ltd.2025-03-27

Legacy Summary#

summary

FDA Review#

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