Pre-Dilatation Balloon Catheter - India CDSCO Medical Device Registration

Pre-Dilatation Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000008_23c041eab041a9dcfc0f82f07b5befd3_0b032c8008d7f490ac93654addbe6b8f. This device is marketed under the brand name X-Change Aspiration Catheter. The license holder is PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Pre-Dilatation Balloon Catheter

UID: MFG/MD/2019/000008_23c041eab041a9dcfc0f82f07b5befd3_0b032c8008d7f490ac93654addbe6b8f

Brand Name

X-Change Aspiration Catheter

License Holder

PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The PTCA Pre Dilatation Catheter is intended for use in patients with clinical symptoms of myocardial ischemia related to the pathological condition of one or more coronary arteries and who are regarded as being candidates for myocardial revascularization. Dilatation of Stenotic portion of Coronary artery