# K990487: Equinox Occlusion Balloon System

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Aug 31, 1999 after 196 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.
27 later devices descend from it; 6 cite it directly.
2 of 28 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) Endeavor Coaxial Catheter: named in the summary without a submission number

## Most influential descendants
- K023548: Proxis Flow-Control Device, Models Eps 101, IC 101 (2003), 6 descendants of its own
- K023914: Coaxia Flocontrol Catheter (2003), 6 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
- K042117: Proxis System, Model Eps 101 (2005), 5 descendants of its own

## Indications for use
The Micro Therapeutics, Inc. Occlusion Balloon Catheter is designed for use in blood vessels where temporary occlusion is desired. The MTI 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/K990487
Methodology: https://510kreport.com/methodology