📋 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 ?
510(k)
Number ?
K130850 ↗
Decision Date ?
June 25, 2013
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used in percutaneous vascular procedures to support the delivery and placement of other interventional devices.
- Used to provide a stable catheter platform during vascular device placement.
Clinical Applications
- Support for guidewire and device delivery during percutaneous vascular interventions.
- Catheter support during procedures involving placement of vascular stents or other interventional devices.
- Navigation and device delivery through challenging vascular anatomy, including tortuous or narrowed vessels.
- Use in venous interventions when catheter support is needed for placement of another device.
Practical Considerations
- Select catheter size and configuration according to the target vessel, access route, guidewire, and device being delivered.
- Confirm compatibility with the guidewire, sheath, catheter, and therapeutic device before use.
- Handling requires familiarity with catheter advancement, torque, support, and navigation through tortuous anatomy.
- The FDA record and supplied information do not establish MRI safety; review the current product labeling before MRI exposure.
- Use is contraindicated or inappropriate when percutaneous vascular catheterization is unsafe, including when the access vessel cannot safely accommodate the device.
Procedures that use this device
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.