# K021066: Modification to Hyperglide Occlusion Balloon System

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Jun 18, 2002 after 77 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.
11 later devices descend from it; 4 cite 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)
- 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
- K090728: Hyperglide Occlusion Balloon System (2009), 10 descendants of its own
- 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

## Indications for use
The MTI HyperGlide Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The MTI Modified 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/K021066
Methodology: https://510kreport.com/methodology