# K221294: preCARDIA Occlusion System

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Jun 30, 2023 after 422 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)
- K210358: Neurescue device, Neurescue Aps (2021) Summary page 5.

## Indications for use
The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.

Source page: https://510kreport.com/device/K221294
Methodology: https://510kreport.com/methodology