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intk-08 8 french introducer kit w side
Sorensen Research
Summary: The intk-08 8 French Introducer Kit is a medical device used for vascular access, particularly in procedures requiring the introduction of catheters. It is commonly used by interventional radiologists and surgeons.
FDA Clearance Information
Pathway
510K
Number
K812325 ↗
Decision Date
September 21, 1981
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intk-08 8 French Introducer Kit by Sorensen Research was cleared through the FDA 510(k) pathway on September 21, 1981. It is classified as a Class 2 medical device under product code DYB.
What It Is
The intk-08 8 French Introducer Kit is designed to facilitate the insertion of catheters into the vascular system. It includes a side port for additional access or infusion capabilities. The device is typically used to establish a stable and reliable entry point for catheters, minimizing trauma to the vessel and reducing the risk of complications.
Clinical Applications
This introducer kit is often used in interventional radiology and surgical settings for procedures such as embolization, central venous catheter placement, and other vascular interventions. It is particularly useful in patients requiring multiple infusions or those with limited peripheral access. The device is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The intk-08 is indicated for use in procedures requiring vascular access, such as the placement of central venous catheters. It is beneficial for patients who need simultaneous infusions of medications, fluids, or nutrition, especially when peripheral access is compromised.
Practical Considerations
The 8 French size is a common choice for introducer kits, balancing ease of insertion with sufficient lumen size for catheter placement. Clinicians should ensure compatibility with the catheters intended for use and be familiar with the technique to minimize complications such as vessel trauma or bleeding.
Related Literature
The linked study explored a technique for placing multiple central venous catheters through a single venipuncture, highlighting the device's utility in complex clinical scenarios. The study found that this approach could reduce the risk of complications like pneumothorax and arterial puncture. However, the study's limitations include its age and potential changes in practice standards since its publication.
Frequently Asked Questions
What is the intk-08 8 French Introducer Kit used for?
It is used for vascular access to facilitate the insertion of catheters, particularly in procedures requiring multiple infusions or central venous access.
What specialties typically use this device?
Interventional radiologists and surgeons commonly use this device in settings such as hospitals and surgical centers.
What are the FDA-cleared indications?
The device is indicated for vascular access in procedures requiring the placement of catheters, especially in patients needing multiple simultaneous infusions.
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.