# K965209: Acat 1 (Arrow Cardiac Assist Technology 1)

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Jan 23, 1998 after 392 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905313 (1991). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
8 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905313: Kontron Intra-Aortic Balloon Pump, Model Kaat II, Kontron Instruments, Inc. (1991) Summary page 1.
- (no number) System 95 & 97 IABP: named in the summary without a submission number
- (no number) TransAct H-8000 IABP: named in the summary without a submission number

## Most influential descendants
- K002256: Arrow Acat 2 Intra-Aortic Balloon Pump (2001), 17 descendants of its own
- 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

## Recalls of this device
- Nov 12, 2007 · Not classified · Z-0549-2008: Leak may occur in the helium drive system for the IABP

## Indications for use
Cardiogenic shock Pre- shock syndrome Post- Infarction angina (Threatening extension of MI) Unstable refractory angina, or impending infraction Ischemia related intractable ventricular dysrhythmias Septic shock syndrome Cardiac contusion Support for diagnostic interventional procedures including: _Cardiac Angiography Coronary Angioplasty (PTCA) Coronary Atherectomy Failed Mitral Valvuloplasty Mechanical complications. due to-acute myocardial infraction:- - -~ Valvular stenosis - Mitral stenosis Mitral Valve insufficiency - Mitral regurgitation Ventricular Septal Defect (VSD) Papillary muscle rupture Prophylactic support in preparation for cardiac surgery or high risk cardiac patients undergoing non cardiac surgical procedures Post-surgical myocardial dysfunction Cardiac support following correction of anatomical defects Maintenance of graft patency post coronary bypass surgery Pulsatile flow during cardiopulmonary bypass Mechanical bridge to other assist devices.

Source page: https://510kreport.com/device/K965209
Methodology: https://510kreport.com/methodology