đź“‹ FDA Reference

acs hi-torque cross-it guide wire with hydrocoat hydrophilic coating product family models 1003211h 1003212hj 1003213h 1

Guidant

Summary: The ACS Hi-Torque Cross-It Guide Wire is a medical device used in interventional cardiology for navigating vascular pathways. It is primarily used by cardiologists during procedures like angioplasty.

FDA Clearance Information

Pathway 510K
Decision Date July 15, 1998
Product Code DQX
Device Class Class 2
Evidence 419 studies

The ACS Hi-Torque Cross-It Guide Wire, manufactured by Guidant, was cleared by the FDA via the 510(k) pathway on July 15, 1998. It is classified as a Class II device under product code DQX.

What It Is

The ACS Hi-Torque Cross-It Guide Wire is a specialized guide wire with a hydrophilic coating designed to facilitate the navigation of vascular pathways during interventional procedures. Its hydrophilic coating reduces friction, allowing for smoother passage through blood vessels. This device is particularly useful in complex vascular cases where maneuverability and precision are critical.

Clinical Applications

This guide wire is commonly used in interventional cardiology, particularly during procedures such as percutaneous coronary interventions (PCI) and angioplasty. It is utilized in settings like cardiac catheterization labs and is essential for patients with coronary artery disease requiring revascularization. The device is suitable for adult patients undergoing these procedures.

Indications for Use

The FDA indications for this device include its use in facilitating the placement of catheters and other devices within the vascular system. It is intended for patients requiring intervention for vascular occlusions or blockages.

Practical Considerations

The ACS Hi-Torque Cross-It Guide Wire comes in various sizes to accommodate different vascular anatomies. Its hydrophilic coating requires proper handling to maintain its lubricity. Clinicians should ensure compatibility with other devices used during procedures.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 ACS Hi-Torque Cross-It Guide Wire used for?

It is used to navigate vascular pathways during interventional cardiology procedures, such as angioplasty.

What specialties typically use this device?

Interventional cardiologists primarily use this device in cardiac catheterization labs.

What are the FDA-cleared indications?

The device is indicated for use in facilitating the placement of catheters and other devices within the vascular system for patients with vascular occlusions.

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.

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