CTO PTCA Pre-Dilatation Balloon Catheter - India CDSCO Medical Device Registration

CTO PTCA Pre-Dilatation Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000008_e56e289611202a13df6cae2fe9ccd2bd_717c27c0cb23a22aff329e0e6f7192ab. 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

CTO PTCA Pre-Dilatation Balloon Catheter

UID: MFG/MD/2019/000008_e56e289611202a13df6cae2fe9ccd2bd_717c27c0cb23a22aff329e0e6f7192ab

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

CTO Pre Dilatation Catheter is intended for use to dilate the diseased segments(X-Change Aspiration Catheter) in coronary artery or a coronary bypass, to improve myocardial perfusion. Dilatation of Stenotic portion of artery