# K122628: Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and Accessories

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp., Cardiac Assist Division
- Decided: Sep 6, 2012 after 9 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K892222 (1990). 67 ancestors in all.
No later device cites it as a predicate yet.
8 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120868: Mega (TM) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega (TM) 7.5FR. 40CC Intra-Aortic Balloon Catheter, Datascope Corp., Cardiac Assist Division (2012) Summary page 1.
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Cardiac Assist, Maquet Cardiovascular, LLC (2011) Summary page 1.

## Recalls of this device
- Jun 23, 2023 · Class II · Z-2221-2023: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery
- Jul 27, 2020 · Class II · Z-2836-2020: Potential Endotoxin Contamination
- May 28, 2019 · Class II · Z-1966-2019: The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.

## Indications for use
The SENSATION PLUSTM 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories have the following indications for use: * Refractory Unstable Angina. * Impending Infarction. * Acute Myocardial Infarction. * Refractory Ventricular Failure. * Complications of Acute MI (ie. Acute MR or VSD or papillary muscle rupture) * Cardiogenic Shock. * Support for diagnostic, percutaneous revascularization and interventional procedures. * Ischemia related intractable ventricular arrhythmias. * Septic Shock. * Intraoperative 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. * Myocardial Contusion.. * Mechanical bridge to other assist devices. * Cardiac support following correction of anatomical defects

Source page: https://510kreport.com/device/K122628
Methodology: https://510kreport.com/methodology