# K160598: REBOA Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: Jun 20, 2016 after 110 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: 2 generations back to K093911 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041306: Numed PTS X Sizing Balloon Catheter, NuMED, Inc. (2004) Summary page 4.
- K110903: PTS-X Sizing Balloon Catheter, NuMED, Inc. (2011) Summary page 4.
- K131869: PTS-X Sizing Balloon Catheter, NuMED, Inc. (2013) Summary page 4.
- K152762: Fogarty Occlusion Catheter, Edwards Lifesciences, LLC (2015) Summary page 4.
- K093911: Fogarty Occlusion Catheter, Edwards Lifesciences, LLC (2010) Summary page 4.

## Indications for use
Recommended for temporary occlusion of the aorta.

Source page: https://510kreport.com/device/K160598
Methodology: https://510kreport.com/methodology