# K193440: ER-REBOA PLUS Catheter

- Pathway: 510(k) (Special)
- Applicant: Prytime Medical Devices, Inc.
- Decided: Jan 9, 2020 after 29 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Oct 29, 2020 · Class II · Z-0716-2021: There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.

## Indications for use
The ER-REBOA™ PLUS 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/K193440
Methodology: https://510kreport.com/methodology