Semi Compliant Balloon Dilatation Catheter
- UID
- MFG/MD/2019/000042_1ab0bc718c4545ba9988011e452ef8c9_4cb1bfa0ccb1d4391abc68f2eb535c98
- Device class
- Class D
- Brand name
- Explorer
- License holder
- Dolphin Lifescience India LLP
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Semi compliant Balloon Dilatation Catheter is generally use for pre dilatation ofncoronary artery to determine lesion morphology, lesion length diameter. It is intended for use in the treatment of patients with clinical symptoms of myocardial ischemia related to the pathological condition of one or more coronary arteries. It is therefore indicated to dilate the diseased segment (Explorer) in a coronary artery or a coronary bypass, to improve myocardial perfusion. The patients should fulfill one or more of the following criteria: • Patients must be judged to be acceptable candidates for coronary bypass surgery • Patients with single vessel atherosclerotic lesion(Explorer), non-calcifled, subtotal and accessible to dilatation with guidewire and catheter • Certain multi-vessel diseased patients may also be candidates for this procedure • Certain patients, who have undergone previous coronary bypass surgery with recurrence of symptoms and progression of the disease in the coronary artery, or stenosis and closure of the grafts, may also be candidates
Semi Compliant Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000042_1ab0bc718c4545ba9988011e452ef8c9_4cb1bfa0ccb1d4391abc68f2eb535c98. This device is marketed under the brand name Explorer. The license holder is Dolphin Lifescience India LLP, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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