# K151821: ER-REBOA Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pryor Medical Devices, Inc.
- Decided: Oct 23, 2015 after 109 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003495 (2001). 6 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032869: Cook Coda Balloon Catheter, Cook, Inc. (2003) Summary page 4.
- K150970: Coda LP Balloon Catheter, Cook Incorporated (2015) Summary page 4.
- K002254: Cook Pressure Monitoring Catheter, Cook, Inc. (2001) Summary page 4.

## Most influential descendants
- K170411: ER-REBOA Catheter (2017), 8 descendants of its own
- 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

## Indications for use
The ER-REBOA Catheter is intended for temporary occlusion of large vessels and monitoring of blood pressure.

Source page: https://510kreport.com/device/K151821
Methodology: https://510kreport.com/methodology