đź“‹ FDA Reference

ptca steerable hydrophilic guidewire

Lake Region Mfg.

Summary: The PTCA Steerable Hydrophilic Guidewire is a medical device used in interventional cardiology to navigate through blood vessels during procedures like angioplasty. It is primarily used by cardiologists in hospital settings.

FDA Clearance Information

Pathway 510K
Decision Date July 16, 2004
Product Code DQX
Device Class Class 2
Evidence 419 studies

The PTCA Steerable Hydrophilic Guidewire by Lake Region Mfg. was cleared through the FDA 510k pathway on July 16, 2004. It is classified as a Class 2 device under product code DQX.

What It Is

The PTCA Steerable Hydrophilic Guidewire is a specialized guidewire used in percutaneous transluminal coronary angioplasty (PTCA) procedures. It features a hydrophilic coating that enhances its ability to navigate through the vascular system by reducing friction. The steerable design allows for precise maneuvering through complex vascular anatomy, which is crucial in reaching target lesions in coronary arteries.

Clinical Applications

This guidewire is commonly used in interventional cardiology during procedures such as angioplasty and stent placement. It is particularly useful in cases where the vascular anatomy is tortuous or when accessing distal coronary lesions. Cardiologists in catheterization labs primarily use this device to treat patients with coronary artery disease, often in acute settings like myocardial infarction.

Indications for Use

The FDA-cleared indications for this guidewire include its use in facilitating the placement of devices during coronary interventions. It is intended for patients requiring treatment for coronary artery disease, where navigating through the coronary vasculature is necessary.

Practical Considerations

Clinicians should consider the typical sizing of the guidewire, which is compatible with standard catheter sizes used in coronary interventions. The hydrophilic coating requires proper handling to maintain its lubricity, and care should be taken to avoid kinking during insertion and navigation.

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 PTCA Steerable Hydrophilic Guidewire used for?

It is used to navigate through blood vessels during coronary interventions like angioplasty.

What specialties typically use this device?

Interventional cardiologists typically use this device in catheterization labs.

What are the FDA-cleared indications?

The guidewire is indicated for use in facilitating device placement during coronary interventions for patients with coronary artery disease.

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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