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FDA 510(k)

J-CATH, GISH MODEL NO. JVAC-XXXX

K-Number: K863790 · 1987-06-24

ApplicantGish Biomedical, Inc.
Decision Date1987-06-24
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

J-CATH, GISH MODEL NO. JVAC-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 1987-06-24 under 510(k) number K863790. 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 J-CATH, GISH MODEL NO. JVAC-XXXX?

J-CATH, GISH MODEL NO. JVAC-XXXX is a medical device that received FDA 510(k) clearance on 1987-06-24. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K863790.

When did J-CATH, GISH MODEL NO. JVAC-XXXX receive FDA 510(k) clearance?

J-CATH, GISH MODEL NO. JVAC-XXXX received FDA 510(k) clearance on 1987-06-24, under 510(k) number K863790.

Who is the listed applicant for J-CATH, GISH MODEL NO. JVAC-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 J-CATH, GISH MODEL NO. JVAC-XXXX?

The FDA product code for J-CATH, GISH MODEL NO. JVAC-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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