FDA.reportPublic FDA data

510(k) K880287

Device
TRU-TRAC COILED GUIDEWIRE
Applicant
N-S MEDICAL PRODUCTS
510(k) number
K880287
Product code
DQX  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-12
Date received
1988-01-25
Regulation
870.1330
Classification name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KEITH L STAHL
Address
4435 SW 35th Ter. Suite 360 Gainesville FL US 32608 32608

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases