# K960832: Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Interventional Therapeutics Corp.
- Decided: May 29, 1996 after 90 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993292: Boston Scientific/Target Sentry Occlusion Balloon Catheter (2000), 6 descendants of its own
- K080861: Micrus Ascent Occlusion Balloon Catheter (2008), 4 descendants of its own
- K091504: Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon Catheter 4X10MM,4X15, Model BRS 00 (2009), 3 descendants of its own
- K103780: Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon Catheter 6X9 MM; Micrus Summit Occlusio (2011), 2 descendants of its own
- K142692: Occlusion Balloon Catheter (2015), 1 descendant of its own

Source page: https://510kreport.com/device/K960832
Methodology: https://510kreport.com/methodology