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 ?
510(k)
Number ?
K041624 ↗
Decision Date ?
July 16, 2004
Product Code ?
DQX Wire, Guide, Catheter
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.
FDA-Cleared Indications
- Facilitation of the placement of interventional devices during coronary interventions.
- Navigation through the coronary vasculature to support treatment of coronary artery lesions.
- Use as an accessory during percutaneous transluminal coronary angioplasty procedures.
Clinical Applications
- Guiding balloon catheters during coronary angioplasty.
- Facilitating placement of coronary stent-delivery systems and other interventional devices.
- Crossing and accessing coronary lesions during percutaneous coronary intervention.
- Navigating tortuous or distal coronary anatomy when coronary device placement is required.
Practical Considerations
- The guidewire must be compatible with the selected guiding catheter, balloon catheter, stent-delivery system and other procedure-specific equipment.
- Hydrophilic coatings require wetting and careful handling according to the device instructions for use to preserve lubricity.
- Avoid excessive force, sharp bending and kinking, which can damage the wire or injure the vessel.
- The device is intended for use by trained clinicians under fluoroscopic guidance in a catheterization laboratory.
- MRI safety depends on the exact device labeling and whether the guidewire remains in the patient; verify the current manufacturer instructions before MRI.
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 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.