# K011656: Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: Jun 20, 2001 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
No predicates in its family tree.
21 later devices descend from it; 5 cite it directly.
2 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MTI Equinox™ Occlusion Balloon Catheter: 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
- K021210: Arteria Occlusion Balloon (2002), 6 descendants of its own
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K110741: Scepter C Occlusion Balloon Catheter (2011), 4 descendants of its own
- K080861: Micrus Ascent Occlusion Balloon Catheter (2008), 4 descendants of its own

## Indications for use
The MTI HyperForm™ Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The MTI HyperForm™ Occlusion Balloon Catheter 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/K011656
Methodology: https://510kreport.com/methodology