Thrombectomy Device - India CDSCO Medical Device Registration
Thrombectomy Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000537_7a75b2c01ef04d31925d7499de13e71b_c2634798e8346aef44ba3f634793b57c. 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 purpose of pRESET Thrombectomy Devices is acute treatment of ischemic stroke by removal of thrombi from intracranial vessels e.g., the internal carotid artery, middle cerebral artery, or basilar artery or from vessels situated distally of them, with a temporary contact duration less than 60 minutes. INDICATIONS: The pRESET Thrombectomy Device is designed for mechanical clot retrieval from intracranial arteries as acute ischemic stroke treatment ▪ for patients who are ineligible for intravenous thrombolysis or ▪ for patients who failed thrombolysis therapy and ▪ as a supplement treatment of an initiated thrombolysis therapy
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