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FDA 510(k)

BLOOD CARDIOPLEGIA STAINLESS STEEL COOL

K-Number: K831157 · 1983-05-09

ApplicantAmerican Bentley
Decision Date1983-05-09
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD CARDIOPLEGIA STAINLESS STEEL COOL is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831157. 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 BLOOD CARDIOPLEGIA STAINLESS STEEL COOL?

BLOOD CARDIOPLEGIA STAINLESS STEEL COOL is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is American Bentley. The 510(k) number is K831157.

When did BLOOD CARDIOPLEGIA STAINLESS STEEL COOL receive FDA 510(k) clearance?

BLOOD CARDIOPLEGIA STAINLESS STEEL COOL received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831157.

Who is the listed applicant for BLOOD CARDIOPLEGIA STAINLESS STEEL COOL?

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 BLOOD CARDIOPLEGIA STAINLESS STEEL COOL?

The FDA product code for BLOOD CARDIOPLEGIA STAINLESS STEEL COOL is DTR.

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Related Devices (Code: DTR)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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