đź“‹ FDA Reference
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 ?
510(k)
Number ?
K220331 ↗
Decision Date ?
July 29, 2022
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Use during endovascular procedures to assist with the placement of stents or other therapeutic devices.
- Temporary occlusion of a blood vessel when vascular flow control is needed to facilitate device placement.
Clinical Applications
- Providing temporary blood-flow control during endovascular stent placement.
- Supporting the delivery and positioning of other endovascular therapeutic devices.
- Maintaining catheter stability during procedures that require precise device deployment.
- Use in selected vascular interventions where temporary balloon occlusion is part of the procedural technique.
Reported off-label uses
- Balloon-assisted flow control during selected thrombectomy procedures, when the treating physician determines that the technique is appropriate.
- Temporary proximal flow arrest during complex endovascular interventions beyond the specific device-placement indication.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The available catheter size, working length, balloon dimensions and recommended inflation volume must be matched to the target vessel and the other devices used.
- Use requires fluoroscopic or other appropriate imaging guidance, careful balloon inflation and complete deflation before catheter repositioning or removal.
- Compatibility with guidewires, introducer sheaths, stents and other endovascular devices should be confirmed in the manufacturer’s instructions for use.
- Contraindications and warnings may include unsuitable vessel size, severe vascular disease, inability to safely access the target vessel, balloon damage or intolerance to the catheter materials.
- MRI safety depends on the exact labeled configuration and whether the catheter is present in the patient; the device labeling should be checked before MRI.
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.
Procedures that use this device
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.