# K090728: Hyperglide Occlusion Balloon System

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Apr 16, 2009 after 28 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: 1 generation back to K011526 (2001). 2 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 13 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.
- (no number) HyperForm Occlusion Balloon System (7mm version): named in the summary without a submission number

## Most influential descendants
- K091458: Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104 (2009), 8 descendants of its own
- K110741: Scepter C Occlusion Balloon Catheter (2011), 4 descendants of its own
- K113698: Scepter XC Occlusion Balloon Catheter (2012), 3 descendants of its own
- K092495: Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 (2009), 3 descendants of its own
- K121785: Scepter C Occlusion Balloon Catheter (2012), 2 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/K090728
Methodology: https://510kreport.com/methodology