# K972113: 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 2, 1997 after 89 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: 2 generations back to K892222 (1990). 8 ancestors in all.
18 later devices descend from it; 1 cites it directly.
5 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963187: Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30 - 40 CC Sensation and Nicath 30C, Boston Scientific Corp (1996) Summary page 1.
- K954431: Percutaneous Intra-Aortic Balloon Catheters, Boston Scientific Corp (1996) Summary page 1.
- K952221: BSC/CA 30 & 40 Sensation, Models 930 & 940, Boston Scientific Corp (1995) Summary page 1.
- K943919: 9.5 FR Sensation DL Intra-Aortic Ballon Catheter, Boston Scientific Corp (1995) Summary page 1.
- K940298: BSC/CA Model 940 Iab, Boston Scientific Corp (1995) Summary page 2.
- K936232: BSC/CA Model 930 Iab, BSC/CA 30 Sidewinder, Boston Scientific Corp (1994) Summary page 2.

## Most influential descendants
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories (1998), 17 descendants of its own
- K994157: Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 (2000), 15 descendants of its own
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B (2001), 14 descendants of its own
- K031569: Datascope CA 40 8FR. Iabs, Model 0684-00-04XX (2003), 12 descendants of its own
- K041281: Datascope 7.5FR. Iab Catheter and Accessories (2004), 11 descendants of its own

## Indications for use
BSC/CA IAB's are indicated for use in patients with the following conditions: * Refractory power failure. * Cardiogenic shock. * Unstable refractory angina. * Hemodynamically significant mechanical complications secondary to acute MI: * Ventricular septal defect. * Mitral valve regurgitation. * Papillary muscle rupture. * Cardiac support for high risk general surgical and coronary angiography/angioplasty patients. * Septic shock. The intended use of the 30 cc and 40 cc SUB-9 remain identical to that of the currently marketed IABC's. All of the devices are intended to provide temporary circulatory support of the left ventricle through controlled mechanical displacement of a volume of blood in the aorta. The mechanical action of the IAB catheter therapy lowers the cardiac workload by two means: 1. Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO2). 2. Diastolic augmentation which provides an increase in the mean aortic pressure and leads to an improvement in systemic and coronary arterial perfusion. Balloon pump therapy is achieved by inserting an intra-aortic balloon catheter into the descending thoracic aorta via the common femoral artery. Balloon inflation is timed to occur during diastole, beginning with the aortic valve closure. The balloon remains inflated until the onset of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.

Source page: https://510kreport.com/device/K972113
Methodology: https://510kreport.com/methodology