FDA 510(k)

CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS

K-Number: K871774 · 1987-08-03

Decision Date1987-08-03

Product CodeDTR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS 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 1987-08-03 under 510(k) number K871774. 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 CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS?

CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS is a medical device that received FDA 510(k) clearance on 1987-08-03. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K871774.

When did CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS receive FDA 510(k) clearance?

CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS received FDA 510(k) clearance on 1987-08-03, under 510(k) number K871774.

Who is the listed applicant for CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS?

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 CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS?

The FDA product code for CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS is 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.