Intra Aortic Balloon Catheter Kit
- UID
- IMP/MD/2018/000069_5edf09b250f42d2f0e3894831e8910b2_601070355bc821893c0d13e7fc6eb883
- Device class
- Class D
- Brand name
- Ultra IABP 7Fr Catheter Kit
- License holder
- M/s. Insightra Medical India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The Insightra Intra Aortic Balloon Catheter Kit has the following indications for use: A. Refractory Unstable Angina. B. Impending Infarction. C. Post infarction angina. D. Refractory left ventricular failure. E. Complications of Acute MI (Ultra IABP 7Fr Catheter Kit). F. Cardiogenic shock. G. Support for diagnostic, percutaneous revascularization and interventional procedures. H. Ischemic related intractable ventricular arrythmias. I. Septic shock. J. Intraoperative pulsatile flow generation. K. Weaning from cardiopulmonary bypass. L. Cardiac support for non-cardiac surgery. M. Prophylactic support in preparation for cardiac surgery. N. Post-surgical myocardial dysfunction/low cardiac output syndrome. O. Cardiac contusion. P. Mechanical bridge to other assist devices. Q. Cardiac support following correction of anatomical defects.
Intra Aortic Balloon Catheter Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000069_5edf09b250f42d2f0e3894831e8910b2_601070355bc821893c0d13e7fc6eb883. This device is marketed under the brand name Ultra IABP 7Fr Catheter Kit. The license holder is M/s. Insightra Medical India Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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