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091 balloon guide catheter
Eosolutions
Summary: The 091 balloon guide catheter by Eosolutions is a medical device used in vascular procedures to facilitate the placement of stents. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K231629 ↗
Decision Date
October 31, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 091 balloon guide catheter by Eosolutions was cleared through the FDA 510k pathway on October 31, 2023. It is classified as a Class 2 device under product code DQY.
What It Is
The 091 balloon guide catheter is a specialized catheter designed to assist in the placement of stents within the vascular system. It features a balloon that can be inflated to temporarily occlude blood flow, providing a stable environment for stent deployment. This device is essential in procedures requiring precise control and positioning of stents, particularly in complex vascular interventions.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings. It is particularly useful in procedures such as percutaneous transluminal coronary angioplasty (PTCA) where precise stent placement is critical. The catheter is used in hospitals and specialized clinics, often for patients with coronary artery disease or other vascular conditions requiring stent placement.
Indications for Use
The 091 balloon guide catheter is indicated for use in patients requiring stent placement in the vascular system. It is designed to aid in the precise deployment of stents in patients with vascular obstructions or narrowing.
Practical Considerations
Clinicians should consider the size of the catheter in relation to the patient's vascular anatomy to ensure compatibility. The device is compatible with standard stent delivery systems and requires familiarity with balloon inflation techniques.
Related Literature
The linked study assessed the design of percutaneous transluminal coronary angioplasty balloon catheters, including the 091 balloon guide catheter. It evaluated performance characteristics such as tip deformation and balloon elongation. While the study provided valuable insights into design features, it was limited by its focus on design rather than clinical outcomes.
Frequently Asked Questions
What is the 091 balloon guide catheter used for?
It is used to facilitate the placement of stents in the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring stent placement in the vascular system to treat obstructions or narrowing.
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.