đź“‹ FDA Reference
hi-torque middle support 012 guide wire with hydrocoat hydrophilic coating
Advanced Cardiovascular Systems
Summary: The Hi-Torque Middle Support 012 Guide Wire is a medical device used primarily in interventional cardiology for navigating vascular systems. It is typically used by cardiologists and interventional radiologists during procedures such as angioplasty.
FDA Clearance Information
Pathway
510K
Number
K012534 ↗
Decision Date
January 24, 2002
Product Code
DQX
Device Class
Class 2
Evidence
419 studies
This device was cleared through the FDA 510(k) pathway on January 24, 2002, by Advanced Cardiovascular Systems. It is classified as a Class 2 device under product code DQX.
What It Is
The Hi-Torque Middle Support 012 Guide Wire is a specialized guide wire featuring a hydrophilic coating known as Hydrocoat, which enhances its maneuverability through blood vessels. The wire is designed to provide optimal support and torque response, making it easier for clinicians to navigate complex vascular pathways during interventional procedures.
Clinical Applications
This guide wire is commonly used in procedures such as coronary angioplasty and stent placement. It is particularly valuable in interventional cardiology and radiology settings, where precise navigation through the vascular system is critical. The device is suitable for adult patients undergoing procedures to treat conditions like coronary artery disease.
Indications for Use
The FDA indications suggest that this guide wire is intended for use in procedures involving the navigation of the vascular system, particularly in cases where liquid embolization agents are used. It is designed to assist in the delivery of therapeutic devices to target sites within the vasculature.
Practical Considerations
The Hi-Torque Middle Support 012 Guide Wire typically comes in various lengths and diameters to accommodate different procedural needs. It is compatible with a range of catheters and embolization devices. Clinicians should be familiar with the hydrophilic coating's handling characteristics to maximize its benefits.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Hi-Torque Middle Support 012 Guide Wire used for?
It is used for navigating the vascular system during interventional procedures such as coronary angioplasty and stent placement.
What specialties typically use this device?
This device is typically used by interventional cardiologists and radiologists.
What are the FDA-cleared indications?
The guide wire is indicated for use in navigating the vascular system, especially in procedures involving liquid embolization agents.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.