Semi Compliant PTCA Balloon Catheter - India CDSCO Medical Device Registration

Semi Compliant PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000227_3f92d51caef5b00feedfb5c4fa65d048_e963892244c9a0d436e7014e39e96e38. This device is marketed under the brand name Racer PC. The license holder is Translumina Therapeutics LLP, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Semi Compliant PTCA Balloon Catheter

UID: MFG/MD/2019/000227_3f92d51caef5b00feedfb5c4fa65d048_e963892244c9a0d436e7014e39e96e38

Brand Name

Racer PC

License Holder

Translumina Therapeutics LLP

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The (Racer PC) 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 reperfusion in patients requiring a percutaneous coronary interventional (Racer PC) procedure in a blood vessel. The (Racer PC) PTCA balloon dilatation catheter is intended for transient use (Racer PC)

Class D

Non-Compliant PTCA Balloon catheter

Brand: Racer PC

Translumina Therapeutics LLP

Class D

Brand: Racer PC

Class D