# K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories

- Pathway: 510(k) (Special)
- Applicant: Cardiac Assist, Maquet Cardiovascular, LLC
- Decided: Sep 9, 2011 after 28 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: 9 generations back to K892222 (1990). 65 ancestors in all.
2 later devices descend from it; 2 cite it directly.
8 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System, Datascope Corp. (2007) Summary page 1.
- K091449: Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02, Datascope Corp., Cardiac Assist Division (2009) Summary page 1.

## Most influential descendants
- K133074: Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and Accessories (2013), 0 descendants of its own
- K122628: Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and Accessories (2012), 0 descendants of its own

## Recalls of this device
- Sep 17, 2024 · Class II · Z-0311-2025: There is discrepant labeling on the inner and outer packaging of the device.

## Indications for use
MAQUET's SENSATION T1.1PLUS 8Fr. 50cc 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 Ml (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. * lntraoperative 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/K112327
Methodology: https://510kreport.com/methodology