# K002256: Arrow Acat 2 Intra-Aortic Balloon Pump

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: May 3, 2001 after 282 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: 2 generations back to K905313 (1991). 6 ancestors in all.
17 later devices descend from it; 3 cite it directly.
8 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983866: Belmont Model Ngpbp Intra-Aortic Balloon Pump, Belmont Instrument Corp. (2000) Summary page 5.
- K965209: Acat 1 (Arrow Cardiac Assist Technology 1), Arrow Intl., Inc. (1998) Summary page 5.
- K905313: Kontron Intra-Aortic Balloon Pump, Model Kaat II, Kontron Instruments, Inc. (1991) Summary page 5.
- K942454: Datascope 95 and 97 Iab Pump Console, Datascope Corp. (1995) Summary page 5.
- K961509: Intra-Aortic Balloon Pump System 97 Modified, Datascope Corp. (1996) Summary page 5.
- K915580: Belmont Model PBP Intra-Aortic Balloon Pump, Belmont Instrument Corp. (1992) Summary page 5.

## Most influential descendants
- K060309: Autocat Intra-Aortic Balloon Pump Series (2006), 14 descendants of its own
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System (2007), 8 descendants of its own
- K162820: AC3 Series IABP System (2017), 4 descendants of its own
- K192238: AC3 Series Intra-Aortic Balloon Pump (IABP) (2019), 3 descendants of its own
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (2011), 3 descendants of its own

## Indications for use
The ACAT 2 Intra-Aortic Balloon Pump 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/K002256
Methodology: https://510kreport.com/methodology