Balloon Dilatation Catheter
- UID
- IMP/MD/2020/000463_16eb53f14e746dc332d80db12a830d7a_fb98be300487e0d2451290e807d1c71c
- Device class
- Class C
- Brand name
- SHUNMEI
- License holder
- SHUNMEI MEDICAL INDIA PRIVATE LIMITED
- Approving authority
- CDSCO
- Product information
- The PTCA balloon dilatation catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The NC coronary dilatation catheter is intended for balloon dilatation of stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and is also indicated for balloon dilatation of a coronary occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction and used for balloon dilatation of stent after implantation
Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000463_16eb53f14e746dc332d80db12a830d7a_fb98be300487e0d2451290e807d1c71c. This device is marketed under the brand name SHUNMEI. The license holder is SHUNMEI MEDICAL INDIA PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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