Intra Aortic Balloon Catheter Kit - India CDSCO Medical Device Registration
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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
Ultra IABP 7Fr Catheter Kit
License Holder
M/s. Insightra Medical India Pvt. Ltd.Device Class
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.
