đź“Š Evidence-Based Reference
primi support catheter
Thermopeutix
Summary: The primi support catheter by Thermopeutix is a Class 2 medical device cleared by the FDA for use in venous stenting procedures. It is primarily used to support catheterization in venous interventions. Current evidence includes three studies, but specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K132701 ↗
Decision Date
September 26, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The primi support catheter was cleared by the FDA through the 510(k) pathway on September 26, 2013. It is manufactured by Thermopeutix and classified as a Class 2 device under product code DQY.
What It Is
The primi support catheter is designed to facilitate catheterization in venous stenting procedures. It aids in the placement and support of stents within venous structures, ensuring proper positioning and stability during interventions.
Clinical Applications
This device is commonly used in clinical scenarios involving venous stenting, where precise catheter support is necessary. It is particularly useful in procedures requiring stable catheter positioning to ensure successful stent deployment.
Evidence Summary
The available literature includes three studies, with publication years ranging from 1987 to 2020. However, the studies provided do not directly relate to the primi support catheter, and specific data on outcomes or safety for this device is not available.
Reported Outcomes
Published studies report no direct outcomes related to the primi support catheter, as the provided evidence does not pertain to this specific device. Therefore, efficacy findings specific to this catheter are not available from the current evidence.
Safety Profile
Reported complications include no specific safety data related to the primi support catheter, as the provided studies do not address this device. Further research is needed to establish a comprehensive safety profile.
Evidence Limitations
The evidence provided does not include studies directly related to the primi support catheter, highlighting a gap in specific efficacy and safety data. Further research is necessary to evaluate the clinical performance and safety of this device in venous stenting procedures.
Frequently Asked Questions
What are the clinical indications for primi support catheter?
The primi support catheter is indicated for use in venous stenting procedures to support catheterization and stent placement.
What outcomes have been reported in clinical studies?
Specific outcomes for the primi support catheter are not available from the provided evidence.
What complications have been reported?
Safety data specific to the primi support catheter is not detailed in the provided evidence.
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.