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FDA 510(k)

CORDIOTOMY RESERVOIR

K-Number: K812008 · 1981-07-28

ApplicantBentley Laboratories, Inc.
Decision Date1981-07-28
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIOTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K812008. 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 CORDIOTOMY RESERVOIR?

CORDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K812008.

When did CORDIOTOMY RESERVOIR receive FDA 510(k) clearance?

CORDIOTOMY RESERVOIR received FDA 510(k) clearance on 1981-07-28, under 510(k) number K812008.

Who is the listed applicant for CORDIOTOMY RESERVOIR?

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

What is the FDA product code for CORDIOTOMY RESERVOIR?

The FDA product code for CORDIOTOMY RESERVOIR is DTN.

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Other records listing Bentley Laboratories, Inc. as applicant

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Related Devices (Code: 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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