Microcatheter - India CDSCO Medical Device Registration
Microcatheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000537_30ac77445ec4fe5f28ced8e10e55bf73_69a77ac5fe32d62c102928621579c771. This device is marketed under the brand name pFMD. The license holder is Sunrise Imaging Systems, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
pFMD
License Holder
Sunrise Imaging SystemsDevice Class
Approving Authority
CDSCO
Product Information
The intended use of pNOVUS 21 is to support the stable access of suitable therapeutic or diagnostic devices, i.e. devices compatible with the inner diameter of the microcatheter, and the infusion of therapeutic and diagnostic agents. The microcatheter is commonly inserted percutaneously into the femoral artery through a sheath or guidecatheter. If transvenous access is desired, a sheath is introduced into a suitable venous access site (pFMD). Time for use is transient. Therefore, the device is normally intended for continuous use of less than 60 minutes. The microcatheter can also be used to guide a catheter with larger inner diameter.
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