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FDA 510(k)

CARDIOVASCULAR DEVICES

K-Number: K820045 · 1982-01-29

ApplicantBentley Laboratories, Inc.
Decision Date1982-01-29
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR DEVICES 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 1982-01-29 under 510(k) number K820045. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVASCULAR DEVICES?

CARDIOVASCULAR DEVICES is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K820045.

When did CARDIOVASCULAR DEVICES receive FDA 510(k) clearance?

CARDIOVASCULAR DEVICES received FDA 510(k) clearance on 1982-01-29, under 510(k) number K820045.

Who is the listed applicant for CARDIOVASCULAR DEVICES?

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 CARDIOVASCULAR DEVICES?

The FDA product code for CARDIOVASCULAR DEVICES is DTM.

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Related PubMed Literature

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PMID: 41276747Regulatory Challenges and Opportunities: A Review of U.S. Food and Drug Administration-Approved Artificial Intelligence and Machine Learning-Enabled Cardiovascular Devices.Therapeutic innovation & regulatory science ()PMID: 39284187Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.Annals of internal medicine ()PMID: 34789308Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA.Trials ()

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: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, 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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