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prowler select 10 and 14 infusion catheters with and without pre-shaped tips
Cordis Neurovascular
Summary: The Prowler Select 10 and 14 infusion catheters are used for the delivery of therapeutic agents in neurovascular procedures. They are primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K020680 ↗
Decision Date
March 27, 2002
Product Code
KRA
Device Class
Class 2
Evidence
0 studies
The Prowler Select infusion catheters were cleared through the FDA 510(k) pathway on March 27, 2002. Manufactured by Cordis Neurovascular, these devices are classified as Class 2 under product code KRA.
What It Is
The Prowler Select infusion catheters are flexible, small-diameter tubes designed to navigate the intricate neurovascular system. They are used to deliver medications or embolic agents directly to the site of pathology, such as aneurysms or arteriovenous malformations. The catheters come in different sizes (10 and 14) and may have pre-shaped tips to facilitate navigation through complex vascular anatomy.
Clinical Applications
These catheters are commonly used in neurointerventional procedures, particularly in the treatment of cerebral aneurysms and other vascular abnormalities. They are essential in settings such as hospitals and specialized clinics where interventional radiology or neurosurgery is performed. The primary patient population includes those with cerebrovascular conditions requiring precise delivery of therapeutic agents.
Indications for Use
The FDA indications suggest that these catheters are intended for use in the neurovascular system to deliver therapeutic agents. This means they are suitable for patients with conditions like cerebral aneurysms or arteriovenous malformations where targeted treatment is necessary.
Practical Considerations
The Prowler Select catheters are available in different sizes to accommodate various anatomical needs. They are compatible with a range of guidewires and embolic agents. Clinicians should be familiar with the catheter's handling characteristics and ensure compatibility with other devices used in the procedure.
Related Literature
The linked study describes a stent remodeling technique used in conjunction with the Prowler Select catheter for coiling ruptured wide-neck cerebral aneurysms. The study highlights the catheter's role in facilitating the delivery of coils and stents to stabilize the aneurysm. While the technique shows promise, the study is limited by its case report nature and the need for further research to validate the findings.
Frequently Asked Questions
What is the Prowler Select infusion catheter used for?
It is used for the delivery of therapeutic agents in neurovascular procedures, such as treating cerebral aneurysms.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device in neurointerventional procedures.
What are the FDA-cleared indications?
The catheters are indicated for use in the neurovascular system to deliver therapeutic agents, suitable for conditions like cerebral aneurysms.
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.