# K214060: LANDMARK REBOA Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Zien Medical Technologies, Inc.
- Decided: Sep 19, 2022 after 266 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: 7 generations back to K003495 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172790: ER-REBOA Catheter, Prytime Medical Devices, Inc. (2017) Summary page 4.

## Indications for use
The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

Source page: https://510kreport.com/device/K214060
Methodology: https://510kreport.com/methodology