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intermediate catheter 105 cm intermediate catheter 115cm intermediate catheter 125cm
Tni Manufacturing
Summary: The intermediate catheter by Tni Manufacturing is a device used in venous stenting procedures. It is FDA 510k cleared and linked to studies focusing on mechanical thrombectomy and other vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K152202 ↗
Decision Date
December 14, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The intermediate catheter received FDA clearance through the 510k pathway on December 14, 2015. It is manufactured by Tni Manufacturing and classified as a Class 2 device.
What It Is
The intermediate catheter is a medical device designed for use in venous stenting procedures. It facilitates access and delivery of therapeutic agents or devices within the vascular system, particularly in intermediate-risk scenarios.
Clinical Applications
This catheter is commonly used in procedures involving venous stenting, such as mechanical thrombectomy for pulmonary embolism. It is suitable for intermediate-risk patients requiring precise vascular intervention.
Evidence Summary
The available literature includes five studies, with publication years ranging from 2004 to 2025. These studies encompass various methodologies, including RCTs and retrospective analyses, focusing on vascular interventions.
Reported Outcomes
Published studies report modest improvements in cardiac index following mechanical thrombectomy in intermediate-risk pulmonary embolism patients. Other studies focus on outcomes related to vascular access and stenting efficacy.
Safety Profile
Reported complications include potential risks associated with vascular interventions, such as bleeding or thrombosis. However, specific adverse events related to the intermediate catheter itself are not detailed in the provided evidence.
Evidence Limitations
The evidence base is limited by the diversity of study designs and the focus on broader vascular interventions rather than the catheter itself. Further research is needed to isolate the catheter's specific efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for intermediate catheter?
The intermediate catheter is indicated for use in venous stenting procedures, particularly in intermediate-risk vascular interventions.
What outcomes have been reported in clinical studies?
Studies report modest improvements in cardiac index post-thrombectomy and focus on vascular access efficacy.
What complications have been reported?
Safety data indicate potential risks like bleeding or thrombosis, common in vascular 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.