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phenom 17 catheter phenom 21 catheter phenom 27 catheter phenom plus catheter
Cathera
Summary: The Phenom catheters by Cathera are used in endovascular procedures to facilitate the delivery of therapeutic devices. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K151638 ↗
Decision Date
November 13, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Phenom catheters received FDA clearance through the 510(k) pathway on November 13, 2015. Manufactured by Cathera, these devices are classified as Class 2 under product code DQY.
What It Is
The Phenom catheters are a series of neurovascular catheters designed for use in minimally invasive procedures. They are used to navigate the vascular system and deliver therapeutic devices to specific sites within the body. The catheters come in various sizes to accommodate different anatomical and procedural needs, offering flexibility and precision in endovascular interventions.
Clinical Applications
Phenom catheters are commonly used in procedures involving the treatment of vascular diseases, such as the placement of stents in venous systems. They are essential tools in interventional radiology and vascular surgery, particularly in settings where precise navigation and delivery of devices are critical. These catheters are often used in hospitals and specialized clinics, catering to patients with conditions requiring endovascular intervention.
Indications for Use
The FDA indications for Phenom catheters include their use in facilitating the delivery of therapeutic devices in the vascular system. They are suitable for patients requiring endovascular treatment, such as those with vascular obstructions or requiring stent placement.
Practical Considerations
Phenom catheters are available in different sizes (17, 21, 27, and Plus) to match the specific requirements of various procedures. They are compatible with a range of therapeutic devices and should be selected based on the target vessel size and procedure type. Clinicians should be familiar with the catheter's handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is Phenom catheter used for?
Phenom catheters are used to navigate the vascular system and deliver therapeutic devices during endovascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use Phenom catheters.
What are the FDA-cleared indications?
The Phenom catheters are indicated for facilitating the delivery of therapeutic devices in the vascular system, particularly in venous interventions.
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.