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FDA 510(k)

CATHCAP, CAT. NO. CC100 SERIES

K-Number: K911519 · 1991-05-22

ApplicantGish Biomedical, Inc.
Decision Date1991-05-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHCAP, CAT. NO. CC100 SERIES 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 1991-05-22 under 510(k) number K911519. 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 CATHCAP, CAT. NO. CC100 SERIES?

CATHCAP, CAT. NO. CC100 SERIES is a medical device that received FDA 510(k) clearance on 1991-05-22. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K911519.

When did CATHCAP, CAT. NO. CC100 SERIES receive FDA 510(k) clearance?

CATHCAP, CAT. NO. CC100 SERIES received FDA 510(k) clearance on 1991-05-22, under 510(k) number K911519.

Who is the listed applicant for CATHCAP, CAT. NO. CC100 SERIES?

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 CATHCAP, CAT. NO. CC100 SERIES?

The FDA product code for CATHCAP, CAT. NO. CC100 SERIES 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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