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FDA 510(k)

CARDIOTOMY RESERVOIR W/FILTER BCR-3500

K-Number: K842620 · 1984-08-27

ApplicantAmerican Bentley
Decision Date1984-08-27
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVOIR W/FILTER BCR-3500 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K842620. 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 RESERVOIR W/FILTER BCR-3500?

CARDIOTOMY RESERVOIR W/FILTER BCR-3500 is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is American Bentley. The 510(k) number is K842620.

When did CARDIOTOMY RESERVOIR W/FILTER BCR-3500 receive FDA 510(k) clearance?

CARDIOTOMY RESERVOIR W/FILTER BCR-3500 received FDA 510(k) clearance on 1984-08-27, under 510(k) number K842620.

Who is the listed applicant for CARDIOTOMY RESERVOIR W/FILTER BCR-3500?

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 RESERVOIR W/FILTER BCR-3500?

The FDA product code for CARDIOTOMY RESERVOIR W/FILTER BCR-3500 is DTN.

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Other records listing American Bentley 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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