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angiomedics cath sheath introduc w hemostasis valv
Angiomedics
Summary: The Angiomedics Cath Sheath Introducer with Hemostasis Valve is a medical device used primarily in vascular procedures to facilitate the introduction of catheters while minimizing blood loss. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K861238 ↗
Decision Date
July 16, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Angiomedics Cath Sheath Introducer with Hemostasis Valve was cleared through the FDA's 510(k) pathway on July 16, 1986. Manufactured by Angiomedics, it is classified as a Class 2 medical device under product code DYB.
What It Is
This device is a catheter sheath introducer equipped with a hemostasis valve, designed to allow the insertion of catheters into blood vessels with minimal blood loss. The hemostasis valve helps to maintain a seal around the catheter, preventing excessive bleeding during procedures. It is an essential tool in interventional procedures where vascular access is required.
Clinical Applications
The Angiomedics Cath Sheath Introducer is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and other catheter-based interventions. It is particularly useful in settings where maintaining hemostasis is critical, such as in patients with coagulopathy or those undergoing complex vascular procedures. The device is suitable for use in hospitals and specialized clinics.
Indications for Use
The device is indicated for use in procedures requiring vascular access, particularly where catheter insertion is necessary. It is suitable for patients undergoing diagnostic or therapeutic interventions involving the vascular system.
Practical Considerations
The device typically comes in various sizes to accommodate different catheter diameters. Compatibility with standard catheter sizes should be verified before use. Clinicians should be familiar with the insertion technique to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Angiomedics Cath Sheath Introducer with Hemostasis Valve used for?
It is used to facilitate the insertion of catheters into blood vessels while minimizing blood loss during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as catheter-based interventions in the vascular system.
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.