# K091449: Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp., Cardiac Assist Division
- Decided: Jun 18, 2009 after 31 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: 8 generations back to K892222 (1990). 46 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041281: Datascope 7.5FR. Iab Catheter and Accessories, Datascope Corp. (2004) Summary page 1.
- K031569: Datascope CA 40 8FR. Iabs, Model 0684-00-04XX, Datascope Corp. (2003) Summary page 1.
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B, Datascope Corp. (2001) Summary page 1.
- K903930: Datascope Percor Stat DL 10.5 FR 50CC, Datascope Corp. (1990) Summary page 1.

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

## Indications for use
Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories have the following indications for use: Refractory unstable angina Impending infarction Acute MI Refractory ventricular failure Complications of acute MI (i.e. 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 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/K091449
Methodology: https://510kreport.com/methodology