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FDA 510(k)

CAP-35 AND CAP35 F

K-Number: K874924 · 1988-01-19

ApplicantGish Biomedical, Inc.
Decision Date1988-01-19
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAP-35 AND CAP35 F 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 1988-01-19 under 510(k) number K874924. The device is classified under product code DTP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAP-35 AND CAP35 F?

CAP-35 AND CAP35 F is a medical device that received FDA 510(k) clearance on 1988-01-19. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K874924.

When did CAP-35 AND CAP35 F receive FDA 510(k) clearance?

CAP-35 AND CAP35 F received FDA 510(k) clearance on 1988-01-19, under 510(k) number K874924.

Who is the listed applicant for CAP-35 AND CAP35 F?

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 CAP-35 AND CAP35 F?

The FDA product code for CAP-35 AND CAP35 F is DTP.

Other records listing Gish Biomedical, Inc. as applicant

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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Related Devices (Code: DTP)

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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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