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FDA 510(k)

SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS

K-Number: K944219 · 1995-06-30

ApplicantGish Biomedical, Inc.
Decision Date1995-06-30
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS 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 1995-06-30 under 510(k) number K944219. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS?

SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS is a medical device that received FDA 510(k) clearance on 1995-06-30. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K944219.

When did SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS receive FDA 510(k) clearance?

SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS received FDA 510(k) clearance on 1995-06-30, under 510(k) number K944219.

Who is the listed applicant for SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS?

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 SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS?

The FDA product code for SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS is DTR.

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Related Devices (Code: DTR)

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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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