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DIAGNOSTIC CATHETER - India CDSCO Medical Device Registration

DIAGNOSTIC CATHETER is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000049_be97826d4dcd2f650eec6fc704424d14_27afbd6e6124fd42a06abf5d5b4229e3. This device is marketed under the brand name Carry. The license holder is Dr. Surgical, 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
DIAGNOSTIC CATHETER
UID: MFG/MD/2019/000049_be97826d4dcd2f650eec6fc704424d14_27afbd6e6124fd42a06abf5d5b4229e3

Brand Name

Carry

License Holder

Dr. Surgical

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The Polaris X steerable Diagnostic catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (Carry) and/or recording of electrical potentials. Excessive bending or kinking of the catheter shaft may damage internal wires, Manual prebending of the distal curve can damage the steering mechanism and /or electrical wire and may cause patient injury. Before using inspect for physical damage including electrical insulation on the cables and the catheter shaft. Replace damaged equipment. Coronery angiography is a diagnostic procedure that allows visualization of the coronary vessels. Fluoroscopy is used to visualize the lumens of the arteries as a 2-D projection. Should these arteries show narrowing or blockage, then techniques exist to open these arteries. Percutaneous coronary intervention is a blanket term that involves the use of mechanical stents, balloons, etc to increase blood flow to previously blocked (Carry) vessels

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