đź“‹ FDA Reference
Prowler Infusion Catheters with Pre-Shaped TIPS
Cordis Neurovascular
Product: Prowler — all models and sizes
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 ?
510(k)
Number ?
K003925 ↗
Decision Date ?
January 8, 2001
Product Code ?
KRA Catheter, Continuous Flush
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.
FDA-Cleared Indications
- Used for the controlled infusion of therapeutic agents into selected vascular sites.
- Used in the vascular system during image-guided catheter-based procedures.
- The FDA record identifies the device as a continuous-flush catheter under product code KRA.
Clinical Applications
- Targeted intra-arterial delivery of therapeutic agents when localized vascular infusion is indicated.
- Catheter-based infusion procedures performed in interventional radiology or neurointerventional suites.
- Navigation through selected vascular pathways using the pre-shaped catheter tip and compatible guidewire.
- Delivery of agents to a selected vascular territory under fluoroscopic or other appropriate imaging guidance.
Practical Considerations
- The pre-shaped tip is selected to match the target vessel and vascular anatomy; available configurations and dimensions vary by specific model.
- The catheter is used with compatible guidewires, infusion equipment, and imaging systems according to the manufacturer’s instructions.
- Use requires trained clinicians familiar with catheter navigation, vascular access, infusion technique, and management of complications such as dissection, perforation, thrombosis, vasospasm, or bleeding.
- MRI safety depends on the exact catheter model and its components; verify the current labeling before MRI examination and do not assume the device is MR safe or MR conditional.
- Contraindications, drug compatibility, maximum infusion parameters, and storage or single-use requirements should be checked in the product-specific instructions for use.
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.