# K062582: Supracor Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Dec 14, 2006 after 105 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: 4 generations back to K892222 (1990). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories, Datascope Corp. (1998) Summary page 1.
- K000729: Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC Universal, Arrow Intl., Inc. (2000) Summary page 1.

## Most influential descendants
- K082746: Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (2009), 0 descendants of its own

## Indications for use
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations: * 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/K062582
Methodology: https://510kreport.com/methodology