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siterite needle guide
Dymax
Summary: The Siterite Needle Guide by Dymax is a device used for ultrasound-guided venous access. It is primarily used in central venous cannulation procedures. Key evidence suggests improved success rates with ultrasound guidance.
FDA Clearance Information
Pathway
510K
Number
K903158 ↗
Decision Date
September 27, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Siterite Needle Guide was cleared by the FDA via the 510(k) pathway on September 27, 1990. It is manufactured by Dymax and classified as a Class 2 device.
What It Is
The Siterite Needle Guide is a medical device designed to assist in ultrasound-guided venous access. It is used to facilitate the accurate placement of needles during central venous cannulation, enhancing precision and reducing complications.
Clinical Applications
Commonly used in central venous cannulation, the Siterite Needle Guide is particularly beneficial in scenarios requiring precise needle placement, such as in patients with challenging anatomy or high BMI. It is often employed in intensive care and surgical settings.
Evidence Summary
The available literature includes three studies ranging from 1997 to 2006, comprising randomized controlled trials and other study types. These studies focus on the efficacy of ultrasound guidance in venous cannulation.
Reported Outcomes
Published studies report that the use of ultrasound guidance, facilitated by devices like the Siterite Needle Guide, improves the success rate of central venous cannulation. The studies highlight enhanced accuracy and reduced complication rates compared to traditional landmark techniques.
Safety Profile
Reported complications include reduced incidence of puncture-related complications when using ultrasound guidance. The studies suggest that ultrasound guidance may lower the risk of arterial puncture and other adverse events associated with blind techniques.
Evidence Limitations
The evidence is limited by the small number of studies and variability in study design. Further research is needed to establish long-term outcomes and to compare different ultrasound-guided techniques.
Frequently Asked Questions
What are the clinical indications for Siterite Needle Guide?
The Siterite Needle Guide is indicated for use in ultrasound-guided central venous cannulation, particularly in patients with challenging anatomy or high BMI.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved success rates and reduced complication rates in central venous cannulation when using ultrasound guidance.
What complications have been reported?
Safety data from evidence indicate a reduction in arterial puncture and other complications compared to traditional landmark-guided techniques.
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.