# K091458: Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104

- Pathway: 510(k) (Traditional)
- Applicant: Ev3 Neurovascular
- Decided: Oct 15, 2009 after 150 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). 5 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001237: Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM Balloon, 4 & 13 MM Tip), (20 MM Balloo, Micro Therapeutics, Inc. (2000)
- K011656: Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771, Micro Therapeutics, Inc. (2001)
- K011526: Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123, Micro Therapeutics, Inc. (2001) Summary page 2.
- K090728: Hyperglide Occlusion Balloon System, Ev3, Inc. (2009) Summary page 1.

## Most influential descendants
- K110741: Scepter C Occlusion Balloon Catheter (2011), 4 descendants of its own
- K113698: Scepter XC Occlusion Balloon Catheter (2012), 3 descendants of its own
- K121785: Scepter C Occlusion Balloon Catheter (2012), 2 descendants of its own
- 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

## Indications for use
The MTI HyperFormTM Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms. The MTI HyperGlideTM Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms.

Source page: https://510kreport.com/device/K091458
Methodology: https://510kreport.com/methodology