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FDA 510(k)

CARDIOTOMY RESERVOIR W/FILTER#BCR-3500

K-Number: K812009 · 1981-07-28

ApplicantBentley Laboratories, Inc.
Decision Date1981-07-28
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 Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K812009. 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 1981-07-28. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K812009.

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 1981-07-28, under 510(k) number K812009.

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

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 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 Bentley Laboratories, Inc. as applicant

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.

K931967HE-30 GOLDK913956BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30K913692VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)K903641QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000QK894826UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLFK874867CATR(TM)-H CARDIOTOMY HOLDER

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Related Devices (Code: DTN)

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

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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