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FDA 510(k)

CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES

K-Number: K883923 · 1988-11-04

ApplicantGish Biomedical, Inc.
Decision Date1988-11-04
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY/VENOUS RESERVOIR NO.: CVR 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 1988-11-04 under 510(k) number K883923. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES?

CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K883923.

When did CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES receive FDA 510(k) clearance?

CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES received FDA 510(k) clearance on 1988-11-04, under 510(k) number K883923.

Who is the listed applicant for CARDIOTOMY/VENOUS RESERVOIR NO.: CVR 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 CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES?

The FDA product code for CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES is DTN.

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Other records listing Gish Biomedical, Inc. as applicant

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Related Devices (Code: DTN)

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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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