# K062202: Occlusion Balloon

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 20, 2006 after 80 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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. The FDA summary names its predicate without a number.
- (no number) Occlusion Balloon Catheter: named in the summary without a submission number
- (no number) Van-Tec Occlusion Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K132990: Occlusion Balloon Catheter (2013), 1 descendant of its own
- K143613: PaxWire Occlusion Balloon System (2015), 0 descendants of its own

## Indications for use
Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. The Occlusion Balloon Catheter product line consists of two specific designs - Standard Occlusion Balloons and BerensteinTM Occlusion Balloon Catheters. Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.

Source page: https://510kreport.com/device/K062202
Methodology: https://510kreport.com/methodology