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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 ?
510(k)
Number ?
K941895 ↗
Decision Date ?
May 24, 1994
Product Code ?
DQX Wire, Guide, Catheter
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.
FDA-Cleared Indications
- Use during PTCA procedures to aid placement of catheters within the coronary arteries.
Clinical Applications
- Guiding PTCA catheters through the coronary arteries during angioplasty.
- Providing a pathway for catheter delivery across coronary artery narrowing or blockage during a labeled PTCA procedure.
Practical Considerations
- The device is identified as a 0.014-inch PTCA guide wire; clinicians should confirm the available length, tip configuration and other specifications before use.
- Confirm compatibility with the selected PTCA balloon catheter, guide catheter and other interventional equipment.
- Hydrophilic coatings can reduce friction when the wire is adequately wetted, but the wire should be handled according to the manufacturer's instructions to reduce the risk of coating damage or vessel injury.
- The record identifies the device as a Class II catheter guide wire under FDA product code DQX. The available summary does not establish MRI safety; MRI conditions should be confirmed from current manufacturer labeling.
- Potential guide-wire complications include vessel dissection or perforation, thrombosis, embolization, vasospasm, arrhythmia and difficulty with wire removal. Patient-specific contraindications and precautions should be assessed by the treating specialist.
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)
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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
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Clinical progress note: Haemophilus influenzae type b.
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Pilot study of social media promotion of home-based self-testing for syphilis.
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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
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Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
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Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
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Frontiers in cellular and infection microbiology
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Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
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Magnetic resonance in medicine
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Nature
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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
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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.