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FDA 510(k)

GISH ARTERIAL FILTER WITH GBS COATING

K-Number: K023833 · 2003-03-31

ApplicantGish Biomedical, Inc.
Decision Date2003-03-31
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GISH ARTERIAL FILTER WITH GBS COATING 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 2003-03-31 under 510(k) number K023833. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GISH ARTERIAL FILTER WITH GBS COATING?

GISH ARTERIAL FILTER WITH GBS COATING is a medical device that received FDA 510(k) clearance on 2003-03-31. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K023833.

When did GISH ARTERIAL FILTER WITH GBS COATING receive FDA 510(k) clearance?

GISH ARTERIAL FILTER WITH GBS COATING received FDA 510(k) clearance on 2003-03-31, under 510(k) number K023833.

Who is the listed applicant for GISH ARTERIAL FILTER WITH GBS COATING?

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 GISH ARTERIAL FILTER WITH GBS COATING?

The FDA product code for GISH ARTERIAL FILTER WITH GBS COATING is DTM.

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Related Devices (Code: DTM)

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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