# K210602: AortaSTAT Occlusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Renalpro Medical, Inc.
- Decided: Jul 9, 2021 after 130 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: 4 generations back to K021721 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183679: Occlusion Balloon Catheter, Qxmedical, LLC (2019) Summary page 4.

## Indications for use
The AortaSTAT Occulsion Device is indicated for temporary vessel occlusion in the suprarenal and infrarenal aorta in applications for perioperative occlusion and emergency control of hemorrhage

Source page: https://510kreport.com/device/K210602
Methodology: https://510kreport.com/methodology