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FDA 510(k)

BJORK-SHILEY AORTIC GRAFT VALVE PROSTH

K-Number: K791225 · 1979-08-10

ApplicantShiley, Inc.
Decision Date1979-08-10
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BJORK-SHILEY AORTIC GRAFT VALVE PROSTH is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1979-08-10 under 510(k) number K791225. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BJORK-SHILEY AORTIC GRAFT VALVE PROSTH?

BJORK-SHILEY AORTIC GRAFT VALVE PROSTH is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Shiley, Inc.. The 510(k) number is K791225.

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

BJORK-SHILEY AORTIC GRAFT VALVE PROSTH received FDA 510(k) clearance on 1979-08-10, under 510(k) number K791225.

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

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 BJORK-SHILEY AORTIC GRAFT VALVE PROSTH?

The FDA product code for BJORK-SHILEY AORTIC GRAFT VALVE PROSTH is DXY. This falls under the Clinical Chemistry category.

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Other records listing Shiley, Inc. as applicant

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Related Devices (Code: DXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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