📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Establishing vascular access for the introduction of compatible catheters and other intravascular devices.
- Providing a temporary access route during diagnostic or therapeutic vascular procedures.
- Allowing additional access through the side port when permitted by the product labeling and procedural technique.
Clinical Applications
- Introducing catheters into the vascular system during interventional procedures.
- Providing vascular access for catheter-based diagnostic studies.
- Providing access during endovascular treatment procedures when an 8 French introducer is appropriate.
- Allowing infusion or pressure monitoring through the side port when compatible with the kit and its labeling.
Practical Considerations
- The 8 French size must be compatible with the outer diameter of the catheter or device being introduced and with the target vessel.
- The access site, sheath length, dilator, guidewire, and catheter should be selected according to the anatomy and planned procedure.
- Common vascular-access risks include bleeding, hematoma, infection, thrombosis, vessel injury, pseudoaneurysm, and embolization.
- Use sterile technique and follow the current manufacturer instructions for preparation, insertion, flushing, side-port use, and removal.
- MRI compatibility cannot be determined from the available FDA record or product name. Confirm the current labeling before use in or near an MRI scanner.
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.
Procedures that use this device
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.