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cannula introducer
Cardiovascular Research
Summary: The cannula introducer by Cardiovascular Research is a device used primarily in procedures requiring vascular access. Key evidence highlights its role in reducing post-lumbar puncture syndrome.
FDA Clearance Information
Pathway
510K
Number
K843118 ↗
Decision Date
November 13, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The cannula introducer was cleared through the FDA 510(k) pathway on November 13, 1984. It is manufactured by Cardiovascular Research and classified as a Class 2 medical device.
What It Is
The cannula introducer is a medical device designed to facilitate the insertion of cannulas into the vascular system. It is commonly used in procedures requiring precise vascular access and is intended for use by trained clinicians.
Clinical Applications
The cannula introducer is frequently used in clinical scenarios such as vascular access for embolization procedures and other interventions requiring precise cannulation. It is particularly useful in reducing trauma during insertion.
Evidence Summary
The available literature includes 12 studies, comprising randomized controlled trials and prospective studies, published between 1993 and 2022. These studies explore various applications and outcomes associated with the use of cannula introducers.
Reported Outcomes
Published studies report that the use of an atraumatic cannula introducer significantly reduces the incidence of post-lumbar puncture syndrome compared to traditional methods. In one study, the incidence was reduced from 31% to 5% with the use of an atraumatic cannula.
Safety Profile
Reported complications include a reduced rate of acute complaints during lumbar puncture when using an atraumatic cannula introducer. No significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for cannula introducer?
The cannula introducer is indicated for use in procedures requiring vascular access, such as embolization and other interventions requiring precise cannulation.
What outcomes have been reported in clinical studies?
Clinical studies have reported a significant reduction in post-lumbar puncture syndrome and acute complaints during procedures when using an atraumatic cannula introducer.
What complications have been reported?
Safety data from evidence indicate a reduction in acute complaints during procedures, with no significant adverse events reported in the reviewed studies.
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.