# K980780: Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B Membrane for Optional Sheathles

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: May 29, 1998 after 88 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: 2 generations back to K905056 (1991). 15 ancestors in all.
16 later devices descend from it; 2 cite it directly.
5 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905056: Percor Stat-DL 9.5 FR W/Opt Insert W/O Intro Sheat, Datascope Corp. (1991) Summary page 1.
- K910997: Datascope Percor Stat Intra-Aortic Balloon, Datascope Corp. (1991) Summary page 1.
- K940178: Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic Balloon Modification, Datascope Corp. (1994) Summary page 1.
- K940231: Intra-Aortic Balloon for Optional Sheathless Insertion, Datascope Corp. (1994) Summary page 1.
- K960166: Percor Stat-DL 9.5 FR. 34 & 40CC, Datascope Corp. (1996) Summary page 2.
- K964987: Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0, Datascope Corp. (1997) Summary page 2.
- K960713: 8 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9FR.Sheath), Arrow Intl., Inc. (1996) Summary page 2.
- K892799: 8 FR Percutan Double Lumen Intra-Aortic Balloon, Kontron Instruments, Inc. (1989) Summary page 2.
- K945230: Arrow Kink Resistant Flexi-Cath Intra-Aortic Balloon, Arrow Intl., Inc. (1995) Summary page 2.
- K963104: 9.5 FR.- Flexi-Cath Intra-Aortic and Control System, Arrow Intl., Inc. (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K943846: Datascope’s Staged Guidewire. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- 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
- 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

## 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/K980780
Methodology: https://510kreport.com/methodology