# K972777: Temporary Occlusion Balloon System

- Pathway: 510(k) (Traditional)
- Applicant: Percu Surge, Inc.
- Decided: Mar 11, 1998 after 229 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031357: Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion System Occlusion Guidewire, 200 CM (2004), 2 descendants of its own
- K062220: Modification to Guarddog Occlusion System (2006), 1 descendant of its own
- K081454: Guarddog Occlusion Guidewire, Inflation Device (2008), 0 descendants of its own

## Indications for use
The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS).

Source page: https://510kreport.com/device/K972777
Methodology: https://510kreport.com/methodology