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FDA 510(k)

ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM

K-Number: K912019 · 1991-10-08

ApplicantGish Biomedical, Inc.
Decision Date1991-10-08
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM 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 1991-10-08 under 510(k) number K912019. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM?

ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-08. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K912019.

When did ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 1991-10-08, under 510(k) number K912019.

Who is the listed applicant for ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM?

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 ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM?

The FDA product code for ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM is CAC.

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Related Devices (Code: CAC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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