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schneider-shiley angioport tm ptca intro w hemo
Angiomedics
Summary: The Schneider-Shiley Angioport TM PTCA Intro w Hemo is a medical device used primarily in interventional cardiology for percutaneous transluminal coronary angioplasty (PTCA) procedures. It is utilized by cardiologists to facilitate the introduction of catheters into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K873195 ↗
Decision Date
December 15, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Schneider-Shiley Angioport TM PTCA Intro w Hemo was cleared through the FDA 510(k) pathway on December 15, 1987. Manufactured by Angiomedics, it is classified as a Class 2 device under product code DYB.
What It Is
The Schneider-Shiley Angioport TM PTCA Intro w Hemo is an introducer sheath designed for use in PTCA procedures. It provides a stable and hemostatic access point for the introduction of catheters into the coronary arteries. The device is engineered to minimize blood loss during catheter exchanges and to facilitate smooth catheter passage.
Clinical Applications
This device is commonly used in interventional cardiology settings, particularly during procedures aimed at treating coronary artery disease. It is employed in catheterization labs by cardiologists to perform angioplasty, where it helps in the precise placement of balloons and stents. The device is suitable for adult patients undergoing coronary interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in PTCA procedures, which are performed to open narrowed or blocked coronary arteries. It is suitable for patients with coronary artery disease requiring catheter-based interventions.
Practical Considerations
The Angioport TM PTCA Intro w Hemo typically comes in various sizes to accommodate different patient anatomies and catheter sizes. It is compatible with standard PTCA catheters and requires careful insertion technique to ensure proper placement and minimize vascular trauma.
Frequently Asked Questions
What is the Schneider-Shiley Angioport TM PTCA Intro w Hemo used for?
It is used to facilitate the introduction of catheters into the coronary arteries during PTCA procedures.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in PTCA procedures to assist in the introduction and exchange of catheters in coronary interventions.
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.