Search Results
Found 1 results
510(k) Data Aggregation
K Number
K082746Device Name
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
Manufacturer
Date Cleared
2009-01-12
(115 days)
Product Code
Regulation Number
870.3535Why did this record match?
Applicant Name (Manufacturer) :
INSIGHTRA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ultra IABP is placed in the descending aorta just below the subclavian artery. and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory feft ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic perculaneous revascularization and interventional procedures, ischemic related intractable ventricular arrhythmias, septic shock, interoperative pulsatile flow generation, weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery, prophylactic support in preparation for cardiac surgery, post-surgical myocardial dysfunction/low cardiac output syndrome, cardiac contusion, mechanical bridge to other assist devices and cardiac support following correction of anatomical defects.
Device Description
The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors).
The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the hearbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.
Ask a Question
Ask a specific question about this device
Page 1 of 1