FDA 510(k), K100635, ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
FDA 510(k), K100635, ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
Device Name: ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
Manufacturer: TRACY MADDOCK
Device Classification Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation Number: LJS
Classification Product Code: KXA
Date Received: 03/05/2010
Decision Date: 08/27/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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