Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315
by Ev3 Neurovascular 510(k)
Active
510(k) K092495
Overview
The Hyperglide Occlusion Balloon System, Models 104-4310 and 104-4315, is a temporary intravascular occluding catheter designed for selective vascular occlusion. It is classified as a Class II medical device and intended for use in both peripheral and neurovascular blood vessels to temporarily stop or control blood flow during interventional procedures.
The system is supplied sterile and intended for single-use. It is regulated under FDA 510K clearance (K092495) and falls under the cardiovascular specialty category. Models are available in specific configurations for targeted occlusion, with compliance and reliability as key design features. Storage and handling must adhere to sterile medical device protocols to ensure proper functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092495 | Date22 Sep 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MJN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ev3 Neurovascular
Questions
What types of blood vessels is the Hyperglide Occlusion Balloon System designed to temporarily occlude, and how does this differ from other occlusion devices?
The Hyperglide Occlusion Balloon System is specifically designed for use in both peripheral and neurovascular blood vessels, allowing for selective vascular occlusion during interventional procedures. Unlike some occlusion devices limited to one vascular category, this system’s dual classification ensures compatibility with both smaller peripheral vessels and delicate neurovascular structures, making it versatile for procedures requiring precise blood flow control.
Is the Hyperglide Occlusion Balloon System reusable, or is it intended for single-use only? What does this mean for my workflow?
The Hyperglide Occlusion Balloon System is intended for single-use only, supplied sterile to ensure patient safety and device reliability. This means each catheter must be discarded after one procedure, reducing the risk of contamination or degradation from repeated use. For workflow efficiency, you’ll need to account for restocking sterile units between cases and follow sterile handling protocols to maintain integrity.
What storage requirements should I follow to keep the Hyperglide Occlusion Balloon System functional and sterile?
Since the system is sterile and single-use, storage must adhere to standard sterile medical device protocols. This includes keeping it in its original packaging until ready for use, protecting it from moisture, extreme temperatures, and physical damage, and ensuring it’s stored in a clean, controlled environment. Always check expiration dates and avoid exposing the device to contaminants that could compromise sterility.
Are there different models of the Hyperglide Occlusion Balloon System, and if so, how do I determine which one is right for my procedure?
Yes, the system includes two models (104-4310 and 104-4315), each designed with specific configurations for targeted occlusion. While the exact differences between models aren’t detailed here, the system’s compliance and reliability are key design features, suggesting they may vary in size, shape, or balloon profile to suit different vascular diameters or procedural needs. Consult the manufacturer’s technical documentation or a product specialist to match the model to your patient’s anatomy and the procedure’s requirements.