đź“Š Evidence-Based Reference
percutaneous introducer
Medamicus
Summary: The percutaneous introducer by Medamicus is a device used primarily for vascular access. It is FDA 510k cleared and linked to 15 studies, highlighting its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K932323 ↗
Decision Date
November 9, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medamicus percutaneous introducer was cleared by the FDA through the 510k pathway on November 9, 1993. It is classified as a Class 2 device under product code DYB.
What It Is
The percutaneous introducer is a medical device used to facilitate vascular access, typically for the insertion of catheters. It is designed for use in procedures requiring the introduction of devices into the vascular system.
Clinical Applications
Commonly used in procedures such as central venous catheterization and pulmonary artery catheterization, the percutaneous introducer is essential in settings requiring reliable vascular access.
Evidence Summary
The literature includes 15 studies, encompassing case reports and other study types, spanning from 2010 to 2024. These studies provide insights into the device's clinical applications and safety.
Reported Outcomes
Published studies report the percutaneous introducer's effectiveness in facilitating vascular access, with successful outcomes in catheter placements. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include rare instances of air embolism and catheter entrapment. These events highlight the importance of careful procedural technique and monitoring.
Evidence Limitations
The evidence is limited by the predominance of case reports and the lack of large-scale randomized controlled trials. Further research is needed to quantify efficacy and refine safety protocols.
Frequently Asked Questions
What are the clinical indications for percutaneous introducer?
The percutaneous introducer is indicated for use in procedures requiring vascular access, such as central venous catheterization and pulmonary artery catheterization.
What outcomes have been reported in clinical studies?
Studies report successful vascular access and catheter placements, though specific efficacy outcomes are not extensively detailed.
What complications have been reported?
Safety data indicate complications such as air embolism and catheter entrapment, underscoring the need for careful procedural execution.
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.