đź“‹ FDA Reference
hdc silcath subclavian catheter percutaneous inser
Hdc
Summary: The HDC Silcath Subclavian Catheter is a percutaneous insertion device used primarily for vascular access in various medical settings. It is typically utilized by healthcare professionals in specialties such as interventional radiology and critical care.
FDA Clearance Information
Pathway
510K
Number
K851078 ↗
Decision Date
April 19, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The HDC Silcath Subclavian Catheter received FDA clearance through the 510(k) pathway on April 19, 1985. Manufactured by Hdc, it is classified as a Class 2 medical device under product code DYB.
What It Is
The HDC Silcath Subclavian Catheter is a medical device designed for percutaneous insertion into the subclavian vein. It facilitates vascular access for the administration of medications, fluids, or for hemodynamic monitoring. The catheter is typically made of biocompatible materials to minimize the risk of infection and thrombosis, and it is designed for ease of insertion and patient comfort.
Clinical Applications
This catheter is commonly used in hospital settings, particularly in intensive care units and during surgical procedures requiring central venous access. It is essential for patients needing long-term intravenous therapy, such as chemotherapy, parenteral nutrition, or in cases of severe trauma where rapid fluid resuscitation is necessary. Interventional radiologists and critical care specialists frequently utilize this device.
Indications for Use
The FDA indications for the HDC Silcath Subclavian Catheter include its use for central venous access in patients requiring intravenous therapy, monitoring, or interventions. It is suitable for patients who need reliable vascular access for extended periods.
Practical Considerations
The HDC Silcath Subclavian Catheter is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard vascular access techniques and equipment. Clinicians should be trained in percutaneous insertion techniques to ensure proper placement and minimize complications.
Frequently Asked Questions
What is the HDC Silcath Subclavian Catheter used for?
It is used for central venous access to administer medications, fluids, or for hemodynamic monitoring.
What specialties typically use this device?
Interventional radiology, critical care, and surgical specialties commonly use this device.
What are the FDA-cleared indications?
The catheter is indicated for central venous access in patients requiring intravenous therapy or monitoring.
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.