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FDA 510(k)

IONESCU-SHILEY AORTIC GRAFT VALVE

K-Number: K803000 · 1981-02-02

ApplicantShiley, Inc.
Decision Date1981-02-02
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IONESCU-SHILEY AORTIC GRAFT VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1981-02-02 under 510(k) number K803000. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONESCU-SHILEY AORTIC GRAFT VALVE?

IONESCU-SHILEY AORTIC GRAFT VALVE is a medical device that received FDA 510(k) clearance on 1981-02-02. The listed applicant is Shiley, Inc.. The 510(k) number is K803000.

When did IONESCU-SHILEY AORTIC GRAFT VALVE receive FDA 510(k) clearance?

IONESCU-SHILEY AORTIC GRAFT VALVE received FDA 510(k) clearance on 1981-02-02, under 510(k) number K803000.

Who is the listed applicant for IONESCU-SHILEY AORTIC GRAFT VALVE?

The FDA 510(k) record lists Shiley, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IONESCU-SHILEY AORTIC GRAFT VALVE?

The FDA product code for IONESCU-SHILEY AORTIC GRAFT VALVE is DSY.

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Other records listing Shiley, Inc. as applicant

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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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