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datascope ptca percutaneous catheter introducer
Datascope
Summary: The Datascope PTCA Percutaneous Catheter Introducer is a medical device used to facilitate the insertion of catheters during percutaneous transluminal coronary angioplasty (PTCA) procedures. It is primarily used by interventional cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K901391 ↗
Decision Date
June 26, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Datascope PTCA Percutaneous Catheter Introducer was cleared through the FDA 510(k) pathway on June 26, 1990. Manufactured by Datascope, it is classified as a Class 2 device under product code DYB.
What It Is
The Datascope PTCA Percutaneous Catheter Introducer is designed to aid in the insertion of catheters into the vascular system during PTCA procedures. It typically consists of a sheath and dilator that help navigate the catheter through the vasculature with minimal trauma. This device is crucial for ensuring smooth and safe catheter placement, reducing the risk of complications during coronary interventions.
Clinical Applications
This device is commonly used in interventional cardiology during procedures such as angioplasty to treat coronary artery disease. It is utilized in catheterization labs within hospitals, where cardiologists perform minimally invasive procedures to open blocked coronary arteries. The introducer is essential for patients requiring coronary interventions, particularly those with complex coronary anatomy.
Indications for Use
The FDA indications for this device include its use in facilitating catheter insertion during PTCA procedures. It is intended for patients undergoing coronary angioplasty, a procedure to restore blood flow in blocked coronary arteries.
Practical Considerations
Clinicians should consider the appropriate sizing of the introducer to match the catheter and patient anatomy. Compatibility with various catheter types is essential, and proper technique in insertion can minimize vascular trauma. Familiarity with the device's handling characteristics can enhance procedural efficiency.
Frequently Asked Questions
What is the Datascope PTCA Percutaneous Catheter Introducer used for?
It is used to facilitate the insertion of catheters during percutaneous transluminal coronary angioplasty (PTCA) procedures.
What specialties typically use this device?
Interventional cardiologists typically use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in facilitating catheter insertion during PTCA procedures, particularly for patients undergoing coronary angioplasty.
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.