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FDA 510(k)

CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX

K-Number: K851004 · 1985-05-16

ApplicantGish Biomedical, Inc.
Decision Date1985-05-16
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX 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 1985-05-16 under 510(k) number K851004. The device is classified under product code DTP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX?

CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX is a medical device that received FDA 510(k) clearance on 1985-05-16. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K851004.

When did CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX receive FDA 510(k) clearance?

CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX received FDA 510(k) clearance on 1985-05-16, under 510(k) number K851004.

Who is the listed applicant for CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX?

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 RESERVOIR BRS-XXX & HOLDER BRS-HXX?

The FDA product code for CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX is DTP.

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Related Devices (Code: DTP)

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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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