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091 balloon guide catheter
Inneuro
Summary: The 091 balloon guide catheter by Inneuro is used in endovascular procedures to assist in the placement of stents or other devices. It is primarily utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K220331 ↗
Decision Date
July 29, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 091 balloon guide catheter by Inneuro was cleared through the FDA 510(k) pathway on July 29, 2022. It is classified as a Class 2 device under product code DQY.
What It Is
The 091 balloon guide catheter is a medical device designed to facilitate the delivery of stents and other therapeutic devices during endovascular procedures. It features a balloon that can be inflated to temporarily occlude blood flow, providing a stable environment for device deployment. This catheter is particularly useful in procedures requiring precise control and positioning within the vascular system.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly in procedures involving the placement of venous stents. It is suitable for use in patients requiring treatment for vascular obstructions or other conditions necessitating endovascular intervention. The catheter's design allows for enhanced control and stability during complex procedures, making it a valuable tool in managing challenging vascular cases.
Indications for Use
The FDA indications suggest that this catheter is intended for use in procedures where temporary vascular occlusion is needed to facilitate the placement of other devices, such as stents. It is suitable for patients with vascular conditions requiring precise device placement.
Practical Considerations
The 091 balloon guide catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and other endovascular devices. Clinicians should be familiar with the inflation and deflation techniques to optimize performance and minimize complications.
Related Literature
The linked study from 2023 evaluated the design and performance characteristics of various percutaneous transluminal coronary angioplasty (PTCA) balloon catheters. Key findings included assessments of tip deformation, balloon elongation, and deflation rates. While the study provides valuable insights into catheter design, it does not specifically address the 091 balloon guide catheter, highlighting a limitation in directly applying these findings.
Frequently Asked Questions
What is the 091 balloon guide catheter used for?
It is used to facilitate the placement of stents and other devices in endovascular procedures by temporarily occluding blood flow.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The catheter is indicated for use in procedures requiring temporary vascular occlusion to aid in the placement of stents or other devices.
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.