# K110903: PTS-X Sizing Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Apr 29, 2011 after 29 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160598: REBOA Balloon Catheter (2016), 0 descendants of its own

## Indications for use
Recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occiuder device.

Source page: https://510kreport.com/device/K110903
Methodology: https://510kreport.com/methodology