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FDA 510(k)

SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX

K-Number: K863791 · 1987-06-25

ApplicantGish Biomedical, Inc.
Decision Date1987-06-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUBCLAVIAN, GISH MODEL NO. SVAC-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 1987-06-25 under 510(k) number K863791. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX?

SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX is a medical device that received FDA 510(k) clearance on 1987-06-25. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K863791.

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

SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX received FDA 510(k) clearance on 1987-06-25, under 510(k) number K863791.

Who is the listed applicant for SUBCLAVIAN, GISH MODEL NO. SVAC-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 SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX?

The FDA product code for SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX is DQY.

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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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