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FDA 510(k)

CARDIOTOMY RESERVORS BCR-3000/3500-Q-120

K-Number: K834373 · 1984-02-04

ApplicantAmerican Bentley
Decision Date1984-02-04
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834373. 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 CARDIOTOMY RESERVORS BCR-3000/3500-Q-120?

CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is American Bentley. The 510(k) number is K834373.

When did CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 receive FDA 510(k) clearance?

CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834373.

Who is the listed applicant for CARDIOTOMY RESERVORS BCR-3000/3500-Q-120?

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 CARDIOTOMY RESERVORS BCR-3000/3500-Q-120?

The FDA product code for CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 is DTN.

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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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