đź“‹ FDA Reference
primi and secondi support catheters
Thermopeutix
Summary: The Primi and Secondi support catheters by Thermopeutix are used in vascular procedures to assist in the placement of other devices. They are typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K130850 ↗
Decision Date
June 25, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Primi and Secondi support catheters were cleared through the FDA 510(k) pathway on June 25, 2013. Manufactured by Thermopeutix, these devices are classified as Class II under product code DQY.
What It Is
The Primi and Secondi support catheters are medical devices designed to facilitate the placement and support of other interventional devices within the vascular system. These catheters provide a stable platform for the delivery of guidewires and other therapeutic devices, enhancing procedural efficiency and safety. They are typically used in minimally invasive procedures to navigate complex vascular anatomy.
Clinical Applications
These support catheters are commonly used in interventional cardiology and radiology settings, particularly during procedures involving the placement of stents or other vascular interventions. They are essential in cases where vascular access is challenging, such as in patients with tortuous or narrowed vessels. The catheters are used in both hospital and outpatient settings, catering to adult and geriatric patients with vascular conditions.
Indications for Use
The FDA-cleared indications for the Primi and Secondi support catheters include their use in vascular procedures to aid in the delivery and support of other devices. They are particularly useful in patients requiring venous stenting or other vascular interventions.
Practical Considerations
The Primi and Secondi support catheters come in various sizes to accommodate different vessel diameters and procedural needs. They are compatible with standard guidewires and are designed for ease of navigation through complex vascular pathways. Clinicians should be familiar with the catheter's handling characteristics and ensure compatibility with other devices used during the procedure.
Frequently Asked Questions
What is Primi and Secondi support catheters used for?
They are used to facilitate the placement and support of other interventional devices within the vascular system, particularly in procedures involving stenting.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use these devices in vascular procedures.
What are the FDA-cleared indications?
The catheters are indicated for use in vascular procedures to assist in the delivery and support of other devices, such as stents, especially in patients with challenging vascular anatomy.
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.