# K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Jan 5, 2007 after 44 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K892222 (1990). 62 ancestors in all.
8 later devices descend from it; 3 cite it directly.
12 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041281: Datascope 7.5FR. Iab Catheter and Accessories, Datascope Corp. (2004) Summary page 1.
- K031636: CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX, Datascope Corp. (2003) Summary page 1.
- 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 2.
- K060309: Autocat Intra-Aortic Balloon Pump Series, Arrow Intl., Inc. (2006) Summary page 2.
- K040801: Intra-Aortic Balloon (Iab), Arrow Intl., Inc. (2004) Summary page 2.
- K021462: Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840, Arrow Intl., Inc. (2002) Summary page 2.
- K981660: Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters, C.R. Bard, Inc. (1998) Summary page 2.

## Most influential descendants
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (2011), 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
- K181122: CARDIOSAVE Intra-Aortic Balloon Pump (2018), 0 descendants of its own
- K172305: CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (2017), 0 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1487-2026: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
- Jun 23, 2023 · Class II · Z-2217-2023: 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
- Jul 27, 2020 · Class II · Z-2835-2020: Potential Endotoxin Contamination
- Jul 27, 2020 · Class II · Z-2834-2020: Potential Endotoxin Contamination
- Dec 16, 2014 · Class II · Z-1062-2015: Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent c
- Mar 21, 2014 · Class I · Z-1523-2014: Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
- Mar 16, 2011 · Not classified · Z-2414-2011: Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.
- May 10, 2010 · Not classified · Z-1812-2010: Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issue
- Feb 4, 2009 · Not classified · Z-1198-2009: Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.
- Nov 19, 2007 · Not classified · Z-0567-2008: Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failur

## Indications for use
CS300 Intra-Aortic Balloon Pump has the following indications for use: The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting. Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has 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/K063525
Methodology: https://510kreport.com/methodology