📋 FDA Reference
Phenom 17 Catheter Phenom 21 Catheter Phenom 27 Catheter Phenom Plus Catheter
Cathera
Product: PhenomTM 17 Catheter — all models and sizes
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 ?
510(k)
Number ?
K151638 ↗
Decision Date ?
November 13, 2015
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitation of the delivery of therapeutic devices within the vascular system during endovascular procedures.
Clinical Applications
- Catheter-based delivery of therapeutic devices to a selected vascular treatment site.
- Endovascular procedures requiring navigation through the vascular system and positioning of another therapeutic device.
- Use as an access and delivery catheter in procedures performed by trained endovascular specialists.
Practical Considerations
- The product family includes Phenom 17, Phenom 21, Phenom 27 and Phenom Plus models; the appropriate size depends on the target vessel, anatomy and therapeutic device.
- Confirm compatibility with the intended guidewire, delivery system and therapeutic device before the procedure.
- The catheter should be advanced under appropriate fluoroscopic or other intravascular imaging guidance by clinicians trained in endovascular techniques.
- Review the current product labeling for contraindications, warnings, maximum pressure, preparation instructions and MRI conditions before use.
- This is a single-use catheter system; it is not intended to be resterilized or reused unless the current labeling specifically states otherwise.
Procedures that use this device
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.