đź“‹ FDA Reference
prowler select 10 14 and plus infusion catheters with and without pre-shaped tips
Cordis Neurovascular
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
510K
Number
K021591 ↗
Decision Date
May 22, 2002
Product Code
KRA
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.
Clinical Applications
These catheters are commonly used in neurovascular interventions, such as the treatment of cerebral aneurysms or arteriovenous malformations, where precise delivery of embolic agents is critical. They are also utilized in peripheral vascular procedures to deliver medications in cases like peripheral artery disease. Interventional radiologists and neurosurgeons frequently use these devices in hospital settings.
Indications for Use
The FDA-cleared indications for these catheters involve the infusion of therapeutic agents into the vascular system. They are suitable for patients requiring targeted delivery of medications or embolic materials, particularly in neurovascular or peripheral vascular conditions.
Practical Considerations
The Prowler Select Infusion Catheters come in various sizes to accommodate different vascular anatomies. Compatibility with other interventional devices, such as guidewires, should be considered during procedure planning. Clinicians should be skilled in catheter navigation techniques to optimize outcomes.
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.