# K994157: Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Mar 13, 2000 after 95 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: 4 generations back to K892222 (1990). 39 ancestors in all.
15 later devices descend from it; 1 cites 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)
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories, Datascope Corp. (1998) Summary page 1.
- K980780: Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B Membrane for Optional Sheathles, Datascope Corp. (1998) Summary page 1.

## Most influential descendants
- 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
- 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

## 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/K994157
Methodology: https://510kreport.com/methodology