# K963187: Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30 - 40 CC Sensation and Nicath 30C

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 4, 1996 after 82 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: 1 generation back to K892222 (1990). 2 ancestors in all.
21 later devices descend from it; 3 cite it directly.
5 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910997: Datascope Percor Stat Intra-Aortic Balloon, Datascope Corp. (1991) Summary page 1.
- K892222: 9.5F Percu Double Lumen Intra-Aortic Balloon, Kontron Instruments, Inc. (1990) Summary page 1.
- (no number) Arrow 9 F 40 cc IAB: named in the summary without a submission number

## Most influential descendants
- K972113: 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel (1997), 18 descendants of its own
- 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

## Indications for use
Refractory power failure. Cardiogenic shock. Unstable refractory angina. Impending or extending myocardial infarction (MI). Hemodynamically significant mechanical complications secondary to acute Mi: * Ventricular septal defect. * Mitral valve regurgitation. * Papillary muscle rupture. Angiography/angioplasty patients. Septal shock.

Source page: https://510kreport.com/device/K963187
Methodology: https://510kreport.com/methodology