FDA 510(k), K073423, MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
FDA 510(k), K073423, MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
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510(k) Number: K073423
Device Name: MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
Device Classification Name: Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant: C.R. BARD, INC.
Regulation Number: 880.5965
Classification Product Code: LJT
Date Received: 12/05/2007
Decision Date: 12/19/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital