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_4443205f570907b9b20df7f9b311764c. 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_4443205f570907b9b20df7f9b311764c

Brand Name

Armada 14 XT PTA Catheter

License Holder

Abbott Healthcare Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Armada 14 XT PTA Catheter is indicated to dilate stenosis in femoral, popliteal, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 mm to 5.0 mm balloon diameters are also indicated for post-dilatation of stents in the peripheral vasculature