# K162820: AC3 Series IABP System

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: Mar 31, 2017 after 175 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905313 (1991). 15 ancestors in all.
4 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)
- K060309: Autocat Intra-Aortic Balloon Pump Series, Arrow Intl., Inc. (2006) Summary page 4.

## Most influential descendants
- K192238: AC3 Series Intra-Aortic Balloon Pump (IABP) (2019), 3 descendants of its own
- 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

## Recalls of this device
- May 20, 2020 · Class I · Z-2416-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret
- May 20, 2020 · Class I · Z-2417-2020: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fret

## Indications for use
The AC3™ Series IABP (Intra-Aortic Balloon Pump) System is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure

Source page: https://510kreport.com/device/K162820
Methodology: https://510kreport.com/methodology