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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K110627
Device Name NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
Applicant
Marvao Medical Devices, Ltd.
368 W. Main St., Suite 7
Northborough,  MA  01532
Applicant Contact Marybeth Gamber
Correspondent
Marvao Medical Devices, Ltd.
368 W. Main St., Suite 7
Northborough,  MA  01532
Correspondent Contact Marybeth Gamber
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/04/2011
Decision Date 08/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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