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FDA 510(k)

DURACATH, GISH MODEL NO. DVAC-XXXX

K-Number: K863792 · 1986-12-05

ApplicantGish Biomedical, Inc.
Decision Date1986-12-05
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DURACATH, GISH MODEL NO. DVAC-XXXX 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 1986-12-05 under 510(k) number K863792. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURACATH, GISH MODEL NO. DVAC-XXXX?

DURACATH, GISH MODEL NO. DVAC-XXXX is a medical device that received FDA 510(k) clearance on 1986-12-05. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K863792.

When did DURACATH, GISH MODEL NO. DVAC-XXXX receive FDA 510(k) clearance?

DURACATH, GISH MODEL NO. DVAC-XXXX received FDA 510(k) clearance on 1986-12-05, under 510(k) number K863792.

Who is the listed applicant for DURACATH, GISH MODEL NO. DVAC-XXXX?

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 DURACATH, GISH MODEL NO. DVAC-XXXX?

The FDA product code for DURACATH, GISH MODEL NO. DVAC-XXXX is BSO.

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Other records listing Gish Biomedical, Inc. as applicant

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Related Devices (Code: BSO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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