FDA 510(k)

VirtuoSaph Plus Endoscopic Vessel Harvesting System

Numéro K : K160206 · 2016-04-21

DemandeurTerumo Cardiovascular Systems Corporation

Date de décision2016-04-21

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K160206.

When did VirtuoSaph Plus Endoscopic Vessel Harvesting System receive FDA 510(k) clearance?

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

Who is the listed applicant for VirtuoSaph Plus Endoscopic Vessel Harvesting System?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Source officielle

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