# K082746: Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20

- Pathway: 510(k) (Traditional)
- Applicant: Insightra Medical, Inc.
- Decided: Jan 12, 2009 after 115 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: 8 generations back to K892222 (1990). 47 ancestors in all.
No later device cites it as a predicate yet.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062582: Supracor Balloon Catheter, Abiomed, Inc. (2006) Summary page 1.
- K041281: Datascope 7.5FR. Iab Catheter and Accessories, Datascope Corp. (2004) Summary page 1.

## Recalls of this device
- Jul 19, 2025 · Class II · Z-2298-2025: Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product

## Indications for use
The Ultra IABP is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory left ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic percutaneous revascularization and interventional procedures, ischemic related intractable ventricular arrhythmias, septic shock, interoperative pulsatile flow generation, weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery, prophylactic support in preparation for cardiac surgery, post-surgical myocardial dysfunction/low cardiac output syndrome, cardiac contusion, mechanical bridge to other assist devices and cardiac support following correction of anatomical defects.

Source page: https://510kreport.com/device/K082746
Methodology: https://510kreport.com/methodology