# K092495: Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315

- Pathway: 510(k) (Special)
- Applicant: Ev3 Neurovascular
- Decided: Sep 22, 2009 after 39 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011526 (2001). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011526: Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123, Micro Therapeutics, Inc. (2001) Summary page 1.
- K021066: Modification to Hyperglide Occlusion Balloon System, Micro Therapeutics, Inc. (2002) Summary page 1.
- K090728: Hyperglide Occlusion Balloon System, Ev3, Inc. (2009) Summary page 1.

## Most influential descendants
- K100063: Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model (2010), 2 descendants of its own
- K101570: Hyperglide and Hyperform Occlusion Balloon Systems (2010), 1 descendant of its own
- K122576: Transform Occlusion Balloon Catheter (Compliant and Super Compliant (2013), 0 descendants of its own

## Indications for use
The HYPERGLIDE Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HYPERGLIDE Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.

Source page: https://510kreport.com/device/K092495
Methodology: https://510kreport.com/methodology