# K201112: AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc.
- Decided: May 27, 2020 after 30 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 11 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K905313 (1991). 17 ancestors in all.
2 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 6.
- K192238: AC3 Series Intra-Aortic Balloon Pump (IABP), Arrow International, Teleflex (2019) Summary page 6.

## Most influential descendants
- 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
- Oct 17, 2022 · Class I · Z-0433-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0434-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0439-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0435-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0436-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0443-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0441-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0442-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0437-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0438-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Oct 17, 2022 · Class I · Z-0440-2023: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

## Indications for use
The AutoCAT®2 Intra-Aortic Balloon Pump (IABP) and AC3™ Series Intra-Aortic Balloon Pump (IABP) are 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/K201112
Methodology: https://510kreport.com/methodology