# K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Nov 2, 2001 after 28 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: 5 generations back to K892222 (1990). 41 ancestors in all.
14 later devices descend from it; 5 cite it directly.
5 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003598: Datascope Profile 8FR. Alt B Iab, 34CC, Datascope Profile 8FR. Alt B Iab, 40CC, Model 0684-000319, 0684-00-0320, Datascope Corp. (2000) Summary page 1.
- K994157: Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329, Datascope Corp. (2000) Summary page 1.
- K943896: Guide Wire for the Use with Datascope Percor Stat-DL Iabs, Datascope Corp. (1995) Summary page 1.

## Most influential descendants
- 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
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System (2007), 8 descendants of its own
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (2011), 3 descendants of its own
- K091449: Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02 (2009), 3 descendants of its own

## Indications for use
The Datascope 8Fr. Polyimide Alt B Intra-Aortic Balloon Catheter has the following indications for use: Refractory ventricular failure. Cardiogenic shock. Unstable refractory angina. Impending infarction. Mechanical complications due to acute myocardial infarction, i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture. Ischemia related intractable ventricular arrhythmias. Cardiac support for high risk general surgical patients and coronary angiography/angioplasty patients. Septic shock. Weaning from cardiopulmonary bypass. Intraoperative pulsatile flow generation. Support for failed angioplasty and valvuloplasty.

Source page: https://510kreport.com/device/K013326
Methodology: https://510kreport.com/methodology