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pinpoint gt safety introducer needle
C.R. Bard
Summary: The Pinpoint GT Safety Introducer Needle by C.R. Bard is a medical device used for vascular access during procedures like embolization. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K142445 ↗
Decision Date
April 13, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinpoint GT Safety Introducer Needle was cleared through the FDA 510k pathway on April 13, 2015. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DYB.
What It Is
The Pinpoint GT Safety Introducer Needle is a specialized needle designed to facilitate safe and precise vascular access. It is used to introduce guidewires or catheters into the vascular system, often as part of interventional procedures. The device incorporates safety features to minimize the risk of accidental needle sticks, enhancing safety for both patients and healthcare providers.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, this device is essential for procedures requiring vascular access, such as the placement of embolization coils. It is used in hospital settings, particularly in catheterization labs and interventional suites. The device is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device include its use in procedures that require vascular access, such as embolization. It is intended for patients needing interventions to treat vascular conditions or abnormalities.
Practical Considerations
The Pinpoint GT Safety Introducer Needle is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and catheters. Clinicians should be trained in vascular access techniques to ensure optimal use of the device.
Frequently Asked Questions
What is the Pinpoint GT Safety Introducer Needle used for?
It is used for gaining vascular access during procedures like embolization, allowing for the introduction of guidewires or catheters.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as the placement of embolization coils.
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.