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FDA 510(k)

OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT

K-Number: K841031 · 1984-05-23

ApplicantAmerican Bentley
Decision Date1984-05-23
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1984-05-23 under 510(k) number K841031. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT?

OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT is a medical device that received FDA 510(k) clearance on 1984-05-23. The listed applicant is American Bentley. The 510(k) number is K841031.

When did OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT receive FDA 510(k) clearance?

OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT received FDA 510(k) clearance on 1984-05-23, under 510(k) number K841031.

Who is the listed applicant for OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT?

The FDA 510(k) record lists American Bentley as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT?

The FDA product code for OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT is DTN.

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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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