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/2021/000761_d7017d691f34d40cafe0f76a3378c108_dfde8dcf958b115f5c0cf5bcd9c2ca8b. This device is marketed under the brand name Ultraverse 035 PTA Dilatation Catheter . The license holder is Becton Dickinson India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Ultraverse 035 PTA Dilatation Catheter
License Holder
Becton Dickinson India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The Ultraverse 035 PTA Dilatation Catheter is 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
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