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The following are the indications for use for the System 96 Intra Aortic Balloon Pump:

• Refractory Ischemia
• Myocardial Infarction
• Preoperative Hemodynamic Stability
• Weaning from Cardio Pulmonary Bypass
• Refractory Ventricular Failure
• Cardiogenic Shock
• Unstable Refractory Angina
• Septic Shock
• Angioplasty Support
• Intraoperative Pulsatile Flow Generation
  Any other uses are not recognized by Datascope Corporation as bonafide.

Datascope System 96 Intra-Aortic Balloon Pump (IABP)

This document is an FDA 510(k) clearance letter for the Datascope System 96 Intra-Aortic Balloon Pump (IABP). It states that the device is substantially equivalent to a predicate device and can be marketed.

However, the provided text DOES NOT contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The document is a regulatory approval, not a scientific study report. It indicates that the device has met the FDA's requirements for substantial equivalence, but it does not detail the specific performance metrics or the studies used to demonstrate those metrics.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. To get this information, you would need to access the actual 510(k) submission from Datascope Corporation (K965236) to the FDA, which would contain the technical data and performance studies.

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