# K170411: ER-REBOA Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Prytime Medical Devices, Inc.
- Decided: Apr 4, 2017 after 53 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: 5 generations back to K003495 (2001). 9 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151821: ER-REBOA Catheter, Pryor Medical Devices, Inc. (2015) Summary page 5.
- K140273: Equalizer Occlusion Balloon Catheter, Boston Scientific Corp (2014) Summary page 5.

## Most influential descendants
- K172790: ER-REBOA Catheter (2017), 4 descendants of its own
- K210358: Neurescue device (2021), 1 descendant of its own
- K200459: pREBOA-PRO Catheter (2020), 1 descendant of its own
- K243795: pREBOA-PRO Catheter (2025), 0 descendants of its own
- K221294: preCARDIA Occlusion System (2023), 0 descendants of its own

## Indications for use
The ER-REBOA™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage

Source page: https://510kreport.com/device/K170411
Methodology: https://510kreport.com/methodology