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FDA 510(k)

CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES

K-Number: K913691 · 1991-12-18

ApplicantGish Biomedical, Inc.
Decision Date1991-12-18
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES 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 1991-12-18 under 510(k) number K913691. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES?

CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K913691.

When did CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES receive FDA 510(k) clearance?

CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES received FDA 510(k) clearance on 1991-12-18, under 510(k) number K913691.

Who is the listed applicant for CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES?

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 CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES?

The FDA product code for CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES is DTR.

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Related Devices (Code: DTR)

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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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