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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 K141634
Device Name NAUTILUS DELTA
Applicant
Romedex International Srl
625 Clayton St.
San Francisco,  CA  94117
Applicant Contact SORIN GRUNWALD
Correspondent
Romedex International Srl
625 Clayton St.
San Francisco,  CA  94117
Correspondent Contact SORIN GRUNWALD
Regulation Number880.5970
Classification Product Code
LJS  
Date Received06/18/2014
Decision Date 01/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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