FDA 510(k), K230775, SOFIA EX Intracranial Support Catheter
FDA 510(k), K230775, SOFIA EX Intracranial Support Catheter
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$149.00 USD
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$149.00 USD
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510(K) Number: K230775
Device Name: SOFIA EX Intracranial Support Catheter
Manufacturer: Miranda Beach
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: 03/21/2023
Date Received: 09/14/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: SOFIA EX Intracranial Support Catheter
Manufacturer: Miranda Beach
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: 03/21/2023
Date Received: 09/14/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology