đź“‹ FDA Reference
scimed 0 014 ptca guide wire with ice hydrophilic coating
Scimed Life Systems
Summary: The Scimed 0 014 PTCA Guide Wire is a medical device used in percutaneous transluminal coronary angioplasty (PTCA) procedures. It is primarily used by interventional cardiologists to facilitate the placement of catheters in coronary arteries.
FDA Clearance Information
Pathway
510K
Number
K941895 ↗
Decision Date
May 24, 1994
Product Code
DQX
Device Class
Class 2
Evidence
419 studies
The Scimed 0 014 PTCA Guide Wire, manufactured by Scimed Life Systems, was cleared through the FDA 510k pathway on May 24, 1994. It is a Class 2 device under product code DQX.
What It Is
The Scimed 0 014 PTCA Guide Wire is a specialized wire used during PTCA procedures to navigate through coronary arteries. It features an ice hydrophilic coating designed to reduce friction and improve maneuverability within the vascular system. This coating also aims to minimize thrombus formation on the wire surface, enhancing procedural safety.
Clinical Applications
This guide wire is commonly used in interventional cardiology during PTCA to treat coronary artery disease. It is essential for navigating complex arterial pathways and is typically used in catheterization labs by cardiologists. The device is suitable for adult patients undergoing angioplasty to restore blood flow in narrowed or blocked coronary arteries.
Indications for Use
The FDA indications suggest that this guide wire is intended for use in PTCA procedures to aid in the placement of catheters within coronary arteries. It is designed for patients with coronary artery disease requiring angioplasty.
Practical Considerations
The Scimed 0 014 PTCA Guide Wire is typically 0.014 inches in diameter, compatible with most standard PTCA catheters. Clinicians should ensure compatibility with other devices used during procedures and be familiar with the handling techniques to maximize the benefits of the hydrophilic coating.
Related Literature
The linked study evaluated thrombus formation on guide wires during PTCA procedures using scanning electron microscopy. It highlighted the importance of coatings in reducing thrombogenicity. While the study provided insights into surface thrombus formation, it was limited by its focus on a specific wire size and did not compare different coating types.
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 Scimed 0 014 PTCA Guide Wire used for?
It is used in PTCA procedures to facilitate the placement of catheters in coronary arteries.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in PTCA procedures to aid in catheter placement within coronary arteries 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.