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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K083194
Device Name VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Applicant Contact JUNKO KUROSAWA
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Correspondent Contact JUNKO KUROSAWA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/29/2008
Decision Date 01/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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