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FDA 510(k)

BJORK-SHILEY PULMONIC GRAFT VALVE

K-Number: K791828 · 1979-09-27

ApplicantShiley, Inc.
Decision Date1979-09-27
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BJORK-SHILEY PULMONIC 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 1979-09-27 under 510(k) number K791828. 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 BJORK-SHILEY PULMONIC GRAFT VALVE?

BJORK-SHILEY PULMONIC GRAFT VALVE is a medical device that received FDA 510(k) clearance on 1979-09-27. The listed applicant is Shiley, Inc.. The 510(k) number is K791828.

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

BJORK-SHILEY PULMONIC GRAFT VALVE received FDA 510(k) clearance on 1979-09-27, under 510(k) number K791828.

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

The FDA product code for BJORK-SHILEY PULMONIC GRAFT VALVE is DSY.

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Other records listing Shiley, Inc. as applicant

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K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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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