PTA Dilatation Catheter - India CDSCO Medical Device Registration

PTA Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000019_d7017d691f34d40cafe0f76a3378c108_81794980e6721bbecb27728ea3410a3b. This device is marketed under the brand name Ultraverse® 035 PTA Dilatation Catheter . The license holder is Bard India Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

PTA Dilatation Catheter

UID: IMP/MD/2018/000019_d7017d691f34d40cafe0f76a3378c108_81794980e6721bbecb27728ea3410a3b

Brand Name

Ultraverse® 035 PTA Dilatation Catheter

License Holder

Bard India Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Intended to dilate stenoses in the peripheral arteries, to treat obstructive lesions of native or synthetic AV fistulae and/or re-expand endoluminal stent graft elements in the iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries