# K131869: PTS-X Sizing Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Aug 8, 2013 after 45 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K160598: REBOA Balloon Catheter (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K131869
Methodology: https://510kreport.com/methodology