Balloon Dilatation Catheter - India CDSCO Medical Device Registration

Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000018_16eb53f14e746dc332d80db12a830d7a_38b8a39157339bc2213b7ff7afd1b100. This device is marketed under the brand name Armada 14 XT PTA Catheter. The license holder is Abbott Healthcare 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

Balloon Dilatation Catheter

UID: IMP/MD/2020/000018_16eb53f14e746dc332d80db12a830d7a_38b8a39157339bc2213b7ff7afd1b100

Brand Name

Armada 14 XT PTA Catheter

License Holder

Abbott Healthcare Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.