# K140273: Equalizer Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 22, 2014 after 169 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
Longest line of descent: 1 generation back to K021721 (2002). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021721: Equalizer Balloon Catheter, Boston Scientific Corp (2002) Summary page 1.

## Most influential descendants
- K170411: ER-REBOA Catheter (2017), 8 descendants of its own
- K172790: ER-REBOA Catheter (2017), 4 descendants of its own
- K153530: Bridge Occlusion Balloon (2016), 4 descendants of its own
- K183679: Occlusion Balloon Catheter (2019), 2 descendants of its own
- K160067: RenovoCath (2017), 2 descendants of its own

## Indications for use
Equalizer"' Occlusion Balloon Catheter isIndicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. Any use for procedures other than those indicated in the instructions is not recommended.

Source page: https://510kreport.com/device/K140273
Methodology: https://510kreport.com/methodology