# K001237: Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM Balloon, 4 & 13 MM Tip), (20 MM Balloo

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: May 18, 2000 after 30 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.
9 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K110741: Scepter C Occlusion Balloon Catheter (2011), 4 descendants of its own
- K113698: Scepter XC Occlusion Balloon Catheter (2012), 3 descendants of its own
- K121785: Scepter C Occlusion Balloon Catheter (2012), 2 descendants of its own
- K100063: Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model (2010), 2 descendants of its own

Source page: https://510kreport.com/device/K001237
Methodology: https://510kreport.com/methodology