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FDA 510(k)

CARDIOPLEGIA ADMINISTRATION SYSTEM CAS

K-Number: K800135 · 1980-02-01

ApplicantBentley Laboratories, Inc.
Decision Date1980-02-01
Product CodeKRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA ADMINISTRATION SYSTEM CAS 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 1980-02-01 under 510(k) number K800135. The device is classified under product code KRJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOPLEGIA ADMINISTRATION SYSTEM CAS?

CARDIOPLEGIA ADMINISTRATION SYSTEM CAS is a medical device that received FDA 510(k) clearance on 1980-02-01. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K800135.

When did CARDIOPLEGIA ADMINISTRATION SYSTEM CAS receive FDA 510(k) clearance?

CARDIOPLEGIA ADMINISTRATION SYSTEM CAS received FDA 510(k) clearance on 1980-02-01, under 510(k) number K800135.

Who is the listed applicant for CARDIOPLEGIA ADMINISTRATION SYSTEM CAS?

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 CARDIOPLEGIA ADMINISTRATION SYSTEM CAS?

The FDA product code for CARDIOPLEGIA ADMINISTRATION SYSTEM CAS is KRJ.

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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: KRJ)

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.

K990276POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K982385POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K940126AVECOR PRE-BYPASS FILTERAvecor Cardiovascular, Inc.K900672PREBYPASS FILTER, CAT. NO. FPB-5American Omni Medical, Inc.K885154INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEMMedtronic Blood Systems, Inc.K884390INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERMedtronic Blood Systems, Inc.

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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