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intradyn pediatric hemostasis introducer
B. Braun Medical
Summary: The Intradyn Pediatric Hemostasis Introducer by B. Braun Medical is a device used primarily in pediatric embolization procedures. Key evidence highlights its use in preventing complications during cardiac interventions.
FDA Clearance Information
Pathway
510K
Number
K033527 ↗
Decision Date
February 5, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Intradyn Pediatric Hemostasis Introducer was cleared by the FDA via the 510(k) pathway on February 5, 2004. It is manufactured by B. Braun Medical and is classified as a Class 2 device.
What It Is
The Intradyn Pediatric Hemostasis Introducer is a medical device designed to facilitate vascular access and hemostasis in pediatric patients. It is primarily used in embolization procedures, particularly in the context of congenital heart disease.
Clinical Applications
Common clinical scenarios for this device include pediatric cardiac interventions where precise vascular access is critical, such as during embolization procedures or when addressing congenital heart anomalies.
Evidence Summary
The available literature includes three studies ranging from 2002 to 2010. These studies encompass various methodologies, including case series and prospective analyses, focusing on pediatric cardiac interventions.
Reported Outcomes
Published studies report that the device is effective in facilitating safe vascular access in pediatric patients undergoing cardiac procedures. The modification of surgical techniques, as noted in one study, helps prevent cardiac perforation and other complications.
Safety Profile
Reported complications include potential cardiac perforation and aortic injury during procedures, which can be mitigated by technique modifications. No specific adverse events related to the device itself were highlighted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse pediatric populations.
Frequently Asked Questions
What are the clinical indications for intradyn pediatric hemostasis introducer?
The device is indicated for use in pediatric patients requiring vascular access for embolization procedures, particularly in the context of congenital heart disease.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of vascular access and prevention of complications such as cardiac perforation during pediatric cardiac interventions.
What complications have been reported?
Safety data indicate potential complications like cardiac perforation and aortic injury, which can be mitigated by procedural modifications.
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.