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gi bleeder od set
Icu Medical
Summary: The GI Bleeder OD Set by Icu Medical is a medical device used for embolization procedures to control gastrointestinal bleeding. It is primarily used by interventional radiologists and gastroenterologists.
FDA Clearance Information
Pathway
510K
Number
K913476 ↗
Decision Date
February 12, 1992
Product Code
KNT
Device Class
Class 2
Evidence
0 studies
The GI Bleeder OD Set was cleared through the FDA 510(k) pathway on February 12, 1992. It is manufactured by Icu Medical and classified as a Class 2 device under product code KNT.
What It Is
The GI Bleeder OD Set is a specialized medical device designed for embolization procedures to manage gastrointestinal bleeding. It typically includes catheters and embolic materials that are used to occlude blood vessels supplying a bleeding site. This device is crucial in controlling hemorrhage in the GI tract, providing a minimally invasive alternative to surgical intervention.
Clinical Applications
This device is commonly used in interventional radiology and gastroenterology for patients experiencing acute gastrointestinal bleeding. It is often employed in hospital settings, particularly in emergency and intensive care units, to stabilize patients with life-threatening hemorrhages. The GI Bleeder OD Set is suitable for a wide range of patients, including those with peptic ulcers, variceal bleeding, or tumors causing vascular erosion.
Indications for Use
The FDA-cleared indication for the GI Bleeder OD Set is for embolization procedures to control bleeding in the gastrointestinal tract. It is intended for patients who present with acute or recurrent GI bleeding that requires intervention to prevent further blood loss.
Practical Considerations
The GI Bleeder OD Set is available in various sizes to accommodate different vascular anatomies. It is compatible with standard angiographic equipment and requires careful handling to ensure precise placement of embolic materials. Clinicians should be trained in embolization techniques to optimize outcomes.
Frequently Asked Questions
What is the GI Bleeder OD Set used for?
The GI Bleeder OD Set is used for embolization procedures to control gastrointestinal bleeding.
What specialties typically use this device?
Interventional radiologists and gastroenterologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for embolization procedures to control bleeding in the gastrointestinal tract.
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.