# K021721: Equalizer Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jun 20, 2002 after 27 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 6 cite it directly.
1 of 34 devices in its family (counting itself) has 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) Large Occlusion Balloon Catheter: named in the summary without a submission number
- (no number) Blue Max Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K140273: Equalizer Occlusion Balloon Catheter (2014), 17 descendants of its own
- K170411: ER-REBOA Catheter (2017), 8 descendants of its own
- K033670: Gore Tri-Lobe Balloon Catheter (2004), 7 descendants of its own
- K172790: ER-REBOA Catheter (2017), 4 descendants of its own
- K153530: Bridge Occlusion Balloon (2016), 4 descendants of its own

## Recalls of this device
- Sep 29, 2009 · Not classified · Z-0194-2010: Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromise
- Sep 29, 2009 · Not classified · Z-0195-2010: Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromise
- Sep 29, 2009 · Not classified · Z-0196-2010: Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromise
- Sep 29, 2009 · Not classified · Z-0197-2010: Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromise

## Indications for use
The Equalizer Balloon is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.

Source page: https://510kreport.com/device/K021721
Methodology: https://510kreport.com/methodology