# K133074: Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and Accessories

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Dec 12, 2013 after 73 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K892222 (1990). 66 ancestors in all.
No later device cites it as a predicate yet.
8 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091449: Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02, Datascope Corp., Cardiac Assist Division (2009) Summary page 1.
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Cardiac Assist, Maquet Cardiovascular, LLC (2011) Summary page 1.

## 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-2222-2023: 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
- Jun 23, 2023 · Class II · Z-2220-2023: 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-1687-2022: Certain lots containing undersized dilator.
- Aug 5, 2022 · Class II · Z-1686-2022: Certain lots containing undersized dilator.
- Aug 5, 2022 · Class II · Z-1685-2022: Certain lots containing undersized dilator.
- Jul 27, 2020 · Class II · Z-2837-2020: Potential Endotoxin Contamination
- Feb 21, 2018 · Class II · Z-1385-2018: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
- Apr 12, 2017 · Class II · Z-2164-2017: Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressu

## Indications for use
The MESA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories have the following Indications for use: * Refractory Unstable Angina. * Impending Infarction. * Acute Myocardial Infarction. * Refractory Ventricular Failure. * Complications of Acute MI (ie.Acute MR or VSD or papillary muscle rupture) * Cardiogenic Shock. * Support for diagnostic, percutaneous revascularization and Interventionall procedures. * Isohemia misated Intractable ventricular arrhythmlas. * Septic Shock. * Inireoperatie pulsatile flow generation. * Weaning from cardiopulmonary bypass. * Cardiac support for non-cardiac surgery. * Prophylactic support in preparation for cardiac surgery. * Post-surgical myocardial dysfunctionlow cardiac output syndrome. * Myocardial Contusion. * Mechanical bridge to other assist devices. * Cardiac support following correction of anatomical defects

Source page: https://510kreport.com/device/K133074
Methodology: https://510kreport.com/methodology