# K010162: Equinox Occulsion Balloon System Model # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: May 18, 2001 after 121 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K010162
Methodology: https://510kreport.com/methodology