# K020257: Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True Sheathless DL 9.5 FR. Iab; Datascope's

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Apr 24, 2002 after 90 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). 50 ancestors in all.
No later device cites it as a predicate yet.
1 of 51 devices in its family (counting itself) has 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) Summary page 1.
- 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.
- 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.
- 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 1.
- K965236: System 96 Intra-Aortic Balloon Pump (Iabp), Datascope Corp. (1997) Summary page 1.
- K002256: Arrow Acat 2 Intra-Aortic Balloon Pump, Arrow Intl., Inc. (2001) Summary page 1.

## Indications for use
Intra-Aortic Balloon Catheter System to be used for the following: 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/K020257
Methodology: https://510kreport.com/methodology