đź“‹ FDA Reference
prowler infusion catheters with pre-shaped tips
Cordis Neurovascular
Summary: The Prowler Infusion Catheters with pre-shaped tips are used for targeted delivery of therapeutic agents in the vasculature. They are primarily used by interventional radiologists and neurovascular specialists.
FDA Clearance Information
Pathway
510K
Number
K003925 ↗
Decision Date
January 8, 2001
Product Code
KRA
Device Class
Class 2
Evidence
0 studies
The Prowler Infusion Catheters were cleared through the FDA 510(k) pathway on January 8, 2001. Manufactured by Cordis Neurovascular, these devices are classified as Class 2 under product code KRA.
What It Is
The Prowler Infusion Catheters are specialized medical devices designed for the delivery of therapeutic agents directly into the vascular system. Featuring pre-shaped tips, these catheters facilitate precise navigation through complex vascular pathways, enhancing the delivery accuracy of medications or contrast agents. Their design supports use in delicate procedures, particularly within the neurovascular system.
Clinical Applications
These catheters are commonly used in interventional radiology and neurovascular procedures, such as embolization or targeted drug delivery. They are particularly valuable in treating conditions like arteriovenous malformations or aneurysms. The devices are used in hospital settings, often in catheterization labs, and are suitable for adult and pediatric patients requiring precise vascular interventions.
Indications for Use
The FDA indications for the Prowler Infusion Catheters include their use in delivering therapeutic agents to specific vascular sites. This is particularly relevant for patients with conditions that require localized treatment, such as vascular anomalies or tumors.
Practical Considerations
The Prowler Infusion Catheters come in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with standard guidewires and imaging systems, ensuring ease of integration into existing procedural workflows. Clinicians should be trained in catheter navigation techniques to optimize outcomes.
Frequently Asked Questions
What is Prowler Infusion Catheters used for?
They are used for the targeted delivery of therapeutic agents within the vascular system, particularly in neurovascular procedures.
What specialties typically use this device?
Interventional radiologists and neurovascular specialists commonly use these catheters.
What are the FDA-cleared indications?
The catheters are indicated for delivering therapeutic agents to specific vascular sites, useful in treating vascular anomalies or tumors.
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.