CDSCO UID IMP/MD/2023/000710_7a75b2c01ef04d31925d7499de13e71b_db8ae6e52fa386a61abf7e9df5392241
Thrombectomy Device
Pack Deal·Device Class Class D·India CDSCO·Brand: pITA
Registration details
- UID
- IMP/MD/2023/000710_7a75b2c01ef04d31925d7499de13e71b_db8ae6e52fa386a61abf7e9df5392241
- Device class
- Class D
- Brand name
- pITA
- License holder
- Pack Deal
- 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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About this record
Thrombectomy Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000710_7a75b2c01ef04d31925d7499de13e71b_db8ae6e52fa386a61abf7e9df5392241. This device is marketed under the brand name pITA. The license holder is Pack Deal, and it is classified as Device Class Class D. The approving authority is CDSCO.
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