Balloon Tipped Cardiac Catheters - India CDSCO Medical Device Registration

Balloon Tipped Cardiac Catheters is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000280_ffa5aec54c852320c3a99bfb290bedc9_dc796e434a13207ba9128280bbdc683c. This device is marketed under the brand name Tyshak, Tyshak II, Tyshak-X, Tyshak Mini, Tyshak NuCLEUS, Z-MED, Z-MED II, Z-MED-X, Z-MED II-X, COEfficient, NuCLEUS, NuCLEUS-X, Mullins-X, Mini Ghost, Z-5. The license holder is Advanced LifeSciences Pvt.ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Balloon Tipped Cardiac Catheters

UID: IMP/MD/2020/000280_ffa5aec54c852320c3a99bfb290bedc9_dc796e434a13207ba9128280bbdc683c

Brand Name

Tyshak, Tyshak II, Tyshak-X, Tyshak Mini, Tyshak NuCLEUS, Z-MED, Z-MED II, Z-MED-X, Z-MED II-X, COEfficient, NuCLEUS, NuCLEUS-X, Mullins-X, Mini Ghost, Z-5

License Holder

Advanced LifeSciences Pvt.ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

The devices are indicated for the following: Percutaneous Transluminal Dilatation (Tyshak, Tyshak II, Tyshak-X, Tyshak Mini, Tyshak NuCLEUS, Z-MED, Z-MED II, Z-MED-X, Z-MED II-X, COEfficient, NuCLEUS, NuCLEUS-X, Mullins-X, Mini Ghost, Z-5), and Percutaneous Transluminal Catheter for Septostomy (Tyshak, Tyshak II, Tyshak-X, Tyshak Mini, Tyshak NuCLEUS, Z-MED, Z-MED II, Z-MED-X, Z-MED II-X, COEfficient, NuCLEUS, NuCLEUS-X, Mullins-X, Mini Ghost, Z-5).