Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-