# K250542: AC3™ Range™ Intra-Aortic Balloon Pump

- Pathway: 510(k) (Special)
- Applicant: Arrow International, LLC
- Decided: Mar 26, 2025 after 30 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K905313 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
7 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232343: AC3™ Series IABP, Arrow International, LLC (2023) Summary page 5.

## Indications for use
The AC3Tm Range Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions: 1. Acute Coronary Syndrome 2. Cardiac and Non-Cardiac Surgery 3. Complications of Heart Failure

Source page: https://510kreport.com/device/K250542
Methodology: https://510kreport.com/methodology