# K964987: Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Mar 17, 1997 after 94 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790775 (1979). 7 ancestors in all.
20 later devices descend from it; 4 cite it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940231: Intra-Aortic Balloon for Optional Sheathless Insertion, Datascope Corp. (1994) 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.
- K905663: Pediatric Intra-Aortic Balloon Catheters, Datascope Corp. (1993) Summary page 1.
- K790775: Intra-Aortic Balloon, Type S, Datascope Corp. (1979) Summary page 1.
- K952221: BSC/CA 30 & 40 Sensation, Models 930 & 940, Boston Scientific Corp (1995) Summary page 1.
- K943919: 9.5 FR Sensation DL Intra-Aortic Ballon Catheter, Boston Scientific Corp (1995) Summary page 2.
- K961358: Arrow Sheathless Intra-Aortic Balloon Catheter, Arrow Intl., Inc. (1996) Summary page 2.

## Most influential descendants
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories (1998), 17 descendants of its own
- K980780: Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B Membrane for Optional Sheathles (1998), 16 descendants of its own
- 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

## Recalls of this device
- Mar 21, 2003 · Not classified · Z-0916-03: 10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.

## Indications for use
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations: Refractory ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock . Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty

Source page: https://510kreport.com/device/K964987
Methodology: https://510kreport.com/methodology