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FDA 510(k)

BLOOD RESERVOIR, CARDIOPULMONARY BYPASS

K-Number: K882414 · 1988-12-05

ApplicantGish Biomedical, Inc.
Decision Date1988-12-05
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD RESERVOIR, CARDIOPULMONARY BYPASS 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 1988-12-05 under 510(k) number K882414. 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 BLOOD RESERVOIR, CARDIOPULMONARY BYPASS?

BLOOD RESERVOIR, CARDIOPULMONARY BYPASS is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K882414.

When did BLOOD RESERVOIR, CARDIOPULMONARY BYPASS receive FDA 510(k) clearance?

BLOOD RESERVOIR, CARDIOPULMONARY BYPASS received FDA 510(k) clearance on 1988-12-05, under 510(k) number K882414.

Who is the listed applicant for BLOOD RESERVOIR, CARDIOPULMONARY BYPASS?

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 BLOOD RESERVOIR, CARDIOPULMONARY BYPASS?

The FDA product code for BLOOD RESERVOIR, CARDIOPULMONARY BYPASS is DTN.

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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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