Cardioplegia Delivery System - India CDSCO Medical Device Registration

Cardioplegia Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000064_c232876123ed8735d065d349de5d4bbb_08a367ab67f6fbb2309fa7a58755c5f1. This device is marketed under the brand name Aortic Punch. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Cardioplegia Delivery System

UID: IMP/MD/2019/000064_c232876123ed8735d065d349de5d4bbb_08a367ab67f6fbb2309fa7a58755c5f1

Brand Name

Aortic Punch

License Holder

India Medtronic Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The MYOtherm XP cardioplegia delivery system is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (Aortic Punch) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

Class B

Manual Retraction Kit

Brand: Aortic Punch

India Medtronic Private Limited

Class B

Class C