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FDA 510(k)

CARDIOPLEGIA RESERVOIR-#500926

K-Number: K831966 · 1983-08-11

ApplicantAmerican Bentley
Decision Date1983-08-11
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA RESERVOIR-#500926 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K831966. 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 CARDIOPLEGIA RESERVOIR-#500926?

CARDIOPLEGIA RESERVOIR-#500926 is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is American Bentley. The 510(k) number is K831966.

When did CARDIOPLEGIA RESERVOIR-#500926 receive FDA 510(k) clearance?

CARDIOPLEGIA RESERVOIR-#500926 received FDA 510(k) clearance on 1983-08-11, under 510(k) number K831966.

Who is the listed applicant for CARDIOPLEGIA RESERVOIR-#500926?

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 CARDIOPLEGIA RESERVOIR-#500926?

The FDA product code for CARDIOPLEGIA RESERVOIR-#500926 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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