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FDA 510(k)

VirtuoSaph Plus Endoscopic Vessel Harvesting System

K-Number: K160206 · 2016-04-21

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2016-04-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VirtuoSaph Plus Endoscopic Vessel Harvesting System is a medical device manufactured by Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2016-04-21 under approval number K160206. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VirtuoSaph Plus Endoscopic Vessel Harvesting System?

VirtuoSaph Plus Endoscopic Vessel Harvesting System is a medical device that received FDA 510(k) clearance on 2016-04-21. It is manufactured by Terumo Cardiovascular Systems Corporation. The 510(k) number is K160206.

When was VirtuoSaph Plus Endoscopic Vessel Harvesting System approved by the FDA?

VirtuoSaph Plus Endoscopic Vessel Harvesting System received FDA 510(k) clearance on 2016-04-21, under approval number K160206.

What company makes VirtuoSaph Plus Endoscopic Vessel Harvesting System?

VirtuoSaph Plus Endoscopic Vessel Harvesting System is manufactured by Terumo Cardiovascular Systems Corporation.

What is the FDA product code for VirtuoSaph Plus Endoscopic Vessel Harvesting System?

The FDA product code for VirtuoSaph Plus Endoscopic Vessel Harvesting System is GEI.

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Other Devices by Terumo Cardiovascular Systems Corporation

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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