VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

Laparoscope, General & Plastic Surgery

TERUMO CARDIOVASCULAR SYSTEMS CORP.

The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Virtuosaph Plus Endoscopic Vessel Harvesting System.

Pre-market Notification Details

Device IDK092789
510k NumberK092789
Device Name:VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor,  MI  48103
ContactChristina Thomas
CorrespondentChristina Thomas
TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor,  MI  48103
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-10
Decision Date2010-05-12
Summary:summary

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