# K070225: Supracor Intr-Aortic Balloon Pump Console

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Dec 13, 2007 after 323 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: 3 generations back to K905313 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031636: CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX, Datascope Corp. (2003) Summary page 1.
- K002256: Arrow Acat 2 Intra-Aortic Balloon Pump, Arrow Intl., Inc. (2001) Summary page 1.

## Indications for use
The Pulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle. Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from: * Unstable refractory angina * Impending infarction * Post Infarction Angina or Threatening Extension of Myocardial Infarction * Refractory ventricular failure * Mechanical complications because of myocardial infarction * Cardiogenic shock * Support and stabilization of high risk patients undergoing diagnostic and non-surgical procedures * Ischemic related intractable ventricular arrhythmias * Septic shock * Interoperative pulsatile flow generation * Weaning from cardiopulmonary bypass * Cardiac support for high risk surgical patients and coronary angiography and angioplasty patients * Prophylactic support in preparation for cardiac surgery * Post-surgical myocardial dysfunction * Cardiac Contusion * Mechanical bridge to other assist devices * Cardiac support following correction of anatomical defects * Support for failed angioplasty and valvuloplasty

Source page: https://510kreport.com/device/K070225
Methodology: https://510kreport.com/methodology