# K132990: Occlusion Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 22, 2013 after 28 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 K062202 (2006). 1 ancestor in all.
1 later device descends 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)
- K062202: Occlusion Balloon, Boston Scientific Corp (2006) Summary page 1.

## Most influential descendants
- K143613: PaxWire Occlusion Balloon System (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K132990
Methodology: https://510kreport.com/methodology