đź“Š Evidence-Based Reference
introducer catheter
Interventional Therapeutics
Summary: The introducer catheter by Interventional Therapeutics is primarily used for vascular access in procedures such as hemodialysis and cardiac surgery. Key evidence highlights complications like thrombosis and rare fatal events.
FDA Clearance Information
Pathway
510K
Number
K915625 ↗
Decision Date
June 3, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer catheter was cleared by the FDA through the 510(k) pathway on June 3, 1992. It is manufactured by Interventional Therapeutics and classified as a Class 2 device.
What It Is
The introducer catheter is a medical device used to facilitate the insertion of other catheters into the vascular system. It is designed for use in procedures requiring vascular access, such as hemodialysis and cardiac catheterization.
Clinical Applications
Commonly used in scenarios requiring vascular access, the introducer catheter is utilized in hemodialysis when an arteriovenous shunt is not feasible and in cardiac surgeries for catheter placement.
Evidence Summary
The literature includes 15 studies, comprising prospective cohorts and case series, published between 2006 and 2022. These studies explore complications and procedural outcomes associated with the device.
Reported Outcomes
Published studies report that the introducer catheter is effective in providing vascular access for hemodialysis and cardiac procedures. However, complications such as thrombosis and rare fatal events during implantation have been documented.
Safety Profile
Reported complications include early-onset thrombosis of the internal jugular vein and rare fatal or near-fatal events during catheter implantation. These highlight the importance of careful procedural execution.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and a focus on specific complications. Further research is needed to explore long-term outcomes and broader safety profiles.
Frequently Asked Questions
What are the clinical indications for introducer catheter?
The introducer catheter is indicated for use in vascular access procedures, such as hemodialysis and cardiac catheterization.
What outcomes have been reported in clinical studies?
Studies report effective vascular access for procedures, but also note complications such as thrombosis and rare fatal events.
What complications have been reported?
Safety data indicate complications like thrombosis of the internal jugular vein and rare fatal or near-fatal events during implantation.
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.