# K101570: Hyperglide and Hyperform Occlusion Balloon Systems

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics Dba Ev3 Neurovascular
- Decided: Jul 13, 2010 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: 4 generations back to K011526 (2001). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990487: Equinox Occlusion Balloon System, Micro Therapeutics, Inc. (1999) Summary page 1.
- 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) Summary page 1.
- K010162: Equinox Occulsion Balloon System Model # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026, Micro Therapeutics, Inc. (2001) Summary page 1.
- 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.
- K011656: Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771, 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.
- K091458: Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104, Ev3 Neurovascular (2009) Summary page 1.
- K092495: Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315, Ev3 Neurovascular (2009) Summary page 1.
- K100063: Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model, Ev3, Inc. (2010)

## Most influential descendants
- K122576: Transform Occlusion Balloon Catheter (Compliant and Super Compliant (2013), 0 descendants of its own

## Indications for use
The ev3 Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer a selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow; the Occlusion Balloon Catheters may also be used in balloon-assisted embolization of intracranial aneurysms.

Source page: https://510kreport.com/device/K101570
Methodology: https://510kreport.com/methodology