đź“‹ FDA Reference
Prowler Select 10 14 and Plus Infusion Catheters with and Without Pre-Shaped TIPS
Cordis Neurovascular
Product: Prowler Select — all models and sizes
Summary: The Prowler Select Infusion Catheters are used for delivering therapeutic agents into the vascular system, primarily in neurovascular and peripheral vascular procedures. They are typically used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K021591 ↗
Decision Date ?
May 22, 2002
Product Code ?
KRA Catheter, Continuous Flush
Device Class ?
Class 2
Evidence ?
0 studies
The Prowler Select Infusion Catheters, manufactured by Cordis Neurovascular, were cleared by the FDA through the 510(k) pathway on May 22, 2002. They are classified as Class 2 devices under product code KRA.
What It Is
The Prowler Select Infusion Catheters are specialized medical devices designed for the delivery of therapeutic agents directly into the vascular system. These catheters are available with or without pre-shaped tips to facilitate navigation through complex vascular anatomy. They are used in minimally invasive procedures to ensure precise delivery of medications or embolic agents.
FDA-Cleared Indications
- Infusion of therapeutic agents into the vascular system.
- Use as a continuous-flush vascular catheter under fluoroscopic guidance when selected for the procedure.
- Available configurations include catheters with and without pre-shaped tips for navigation through vascular anatomy.
Clinical Applications
- Catheter-directed infusion of therapeutic agents into selected blood vessels.
- Delivery of embolic or other therapeutic materials when consistent with the catheter's labeling and compatible with the treatment plan.
- Navigation through tortuous vascular anatomy using a catheter with an appropriate pre-shaped or straight tip.
- Use during minimally invasive vascular procedures in which controlled intravascular infusion is required.
Practical Considerations
- The device is available in Prowler Select 10, 14, and Plus configurations; clinicians should match catheter size, lumen characteristics, and tip shape to the target vessel and intended agent.
- Compatibility with guidewires, guide catheters, contrast media, therapeutic drugs, and embolic materials must be confirmed before use.
- The catheter is advanced under fluoroscopic or other appropriate imaging guidance by clinicians trained in vascular catheterization.
- MRI safety depends on the exact device configuration and labeling; do not assume the catheter is MR Safe or MR Conditional without checking current manufacturer information.
- Potential complications of intravascular catheterization include vessel injury, bleeding, thromboembolism, infection, vasospasm, dissection, and unintended delivery of the infused agent.
Frequently Asked Questions
What is Prowler Select Infusion Catheters used for?
They are used for delivering therapeutic agents into the vascular system, particularly in neurovascular and peripheral vascular procedures.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use these catheters.
What are the FDA-cleared indications?
They are indicated for the infusion of therapeutic agents into the vascular system, suitable for neurovascular and peripheral vascular conditions.
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.