# K031569: Datascope CA 40 8FR. Iabs, Model 0684-00-04XX

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Jun 10, 2003 after 21 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: 6 generations back to K892222 (1990). 42 ancestors in all.
12 later devices descend from it; 3 cite it directly.
5 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B, Datascope Corp. (2001)
- 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.

## Most influential descendants
- 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
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories (2011), 2 descendants of its own

## Indications for use
Datascope’s CA 40 8Fr. Intra-Aortic Balloon Catheters have the following indications for use: Refractory unstable angina Impending infarction Acute MI Refractory ventricular failure Complications of acute MI (Le. 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 bypass Cardiac support for non-cardiac surgery Prophylactic support in preparation for cardiac surgery Post surgical myocardial dysfunctiodlow cardiac output syndrome Myocardial contusion Mechanical bridge to other assist devices Cardiac support following correction of anatomical defects

Source page: https://510kreport.com/device/K031569
Methodology: https://510kreport.com/methodology