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FDA 510(k)

ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS

K-Number: K922840 · 1993-05-17

ApplicantGish Biomedical, Inc.
Decision Date1993-05-17
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1993-05-17 under 510(k) number K922840. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS?

ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS is a medical device that received FDA 510(k) clearance on 1993-05-17. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K922840.

When did ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS receive FDA 510(k) clearance?

ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS received FDA 510(k) clearance on 1993-05-17, under 510(k) number K922840.

Who is the listed applicant for ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS?

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

What is the FDA product code for ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS?

The FDA product code for ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS is DTL.

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Related Devices (Code: DTL)

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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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