# K192238: AC3 Series Intra-Aortic Balloon Pump (IABP)

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Teleflex
- Decided: Nov 12, 2019 after 85 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: 5 generations back to K905313 (1991). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
7 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162820: AC3 Series IABP System, Arrow International, Inc. (2017) Summary page 4.

## Most influential descendants
- K201112: AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (2020), 2 descendants of its own
- K232343: AC3™ Series IABP (2023), 1 descendant of its own
- K250542: AC3™ Range™ Intra-Aortic Balloon Pump (2025), 0 descendants of its own

## Indications for use
The AC3 Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions: • Acute Coronary Syndrome • Cardiac and Non-Cardiac Surgery • Complications of Heart Failure

Source page: https://510kreport.com/device/K192238
Methodology: https://510kreport.com/methodology