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FDA 510(k)

ARTERIAL BLOOD FILTER MODEL #AF-1040

K-Number: K820343 · 1982-06-17

ApplicantBentley Laboratories, Inc.
Decision Date1982-06-17
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTERIAL BLOOD FILTER MODEL #AF-1040 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 1982-06-17 under 510(k) number K820343. 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 ARTERIAL BLOOD FILTER MODEL #AF-1040?

ARTERIAL BLOOD FILTER MODEL #AF-1040 is a medical device that received FDA 510(k) clearance on 1982-06-17. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K820343.

When did ARTERIAL BLOOD FILTER MODEL #AF-1040 receive FDA 510(k) clearance?

ARTERIAL BLOOD FILTER MODEL #AF-1040 received FDA 510(k) clearance on 1982-06-17, under 510(k) number K820343.

Who is the listed applicant for ARTERIAL BLOOD FILTER MODEL #AF-1040?

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 ARTERIAL BLOOD FILTER MODEL #AF-1040?

The FDA product code for ARTERIAL BLOOD FILTER MODEL #AF-1040 is DTM.

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Other records listing Bentley Laboratories, Inc. as applicant

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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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