# K041281: Datascope 7.5FR. Iab Catheter and Accessories

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Jun 7, 2004 after 25 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K892222 (1990). 44 ancestors in all.
11 later devices descend from it; 3 cite it directly.
5 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K002365: Datascope Reinforced Percutaneous Catheter Introducer Set, Datascope Corp. (2000) Summary page 1.

## Most influential descendants
- 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
- K091449: Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02 (2009), 3 descendants of its own
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories (2011), 2 descendants of its own
- K151254: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (2015), 1 descendant of its own

## Recalls of this device
- Sep 17, 2024 · Class II · Z-0311-2025: There is discrepant labeling on the inner and outer packaging of the device.
- Jun 23, 2023 · Class II · Z-2223-2023: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery
- Aug 5, 2022 · Class II · Z-0131-2023: The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initia
- Jul 27, 2020 · Class II · Z-2839-2020: Potential Endotoxin Contamination
- Jul 27, 2020 · Class II · Z-2840-2020: Potential Endotoxin Contamination
- Jul 27, 2020 · Class II · Z-2838-2020: Potential Endotoxin Contamination
- Aug 11, 2014 · Class III · Z-2568-2014: During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.

## Indications for use
Datascope's 7.5Fr. 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/K041281
Methodology: https://510kreport.com/methodology