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occlusion balloon catheter model obc
Cook
Summary: The occlusion balloon catheter model OBC by Cook is a medical device used to temporarily occlude blood vessels. It is primarily used by interventional radiologists and vascular surgeons in procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K101877 ↗
Decision Date
August 6, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The occlusion balloon catheter model OBC was cleared via the FDA 510k pathway on August 6, 2010. Manufactured by Cook, it is a Class 2 device under product code DQY.
What It Is
The occlusion balloon catheter model OBC is a specialized catheter designed to temporarily block blood flow in a vessel. It features an inflatable balloon at its tip, which can be expanded to occlude the vessel when needed. This device is commonly used in procedures requiring temporary vessel occlusion to prevent blood flow during interventions, such as the placement of venous stents.
Clinical Applications
This device is frequently used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the placement of venous stents, where temporary occlusion of the vessel is necessary to ensure proper stent deployment. The catheter is suitable for use in adult patients requiring such interventions, often in hospital or specialized outpatient settings.
Indications for Use
The FDA-cleared indications for this device involve its use in temporarily occluding blood vessels during procedures. It is intended for patients who require interventions that involve the placement of venous stents, ensuring that blood flow is controlled during the procedure.
Practical Considerations
When using the occlusion balloon catheter, clinicians should consider the appropriate sizing for the vessel being occluded. Compatibility with other interventional devices, such as stents, should be verified. Proper technique involves careful inflation of the balloon to avoid vessel damage.
Frequently Asked Questions
What is the occlusion balloon catheter model OBC used for?
It is used to temporarily occlude blood vessels during procedures, particularly in the placement of venous stents.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for temporarily occluding blood vessels during procedures involving venous stents.
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.