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FDA 510(k)

VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

K-Number: K092789 · 2010-05-12

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2010-05-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2010-05-12 under 510(k) number K092789. The device is classified under product code GCJ. It was reviewed by the GU 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 2010-05-12. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K092789.

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 2010-05-12, under 510(k) number K092789.

Who is the listed applicant for VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. 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 GCJ.

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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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