# K100063: Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Feb 2, 2010 after 22 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: 3 generations back to K011526 (2001). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092495: Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315, Ev3 Neurovascular (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.
- K090728: Hyperglide Occlusion Balloon System, Ev3, Inc. (2009) Summary page 1.
- K021066: Modification to Hyperglide Occlusion Balloon System, Micro Therapeutics, Inc. (2002) Summary page 1.
- K011656: Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771, Micro Therapeutics, Inc. (2001) Summary page 1.

## Most influential descendants
- 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 HyperForM TM Occlusion Balloon Catheters are indicated for the 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/K100063
Methodology: https://510kreport.com/methodology