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FDA 510(k)

PEDIATRIC ARTERIAL BLOOD FILTER #AF-5

K-Number: K801147 · 1980-06-04

ApplicantBentley Laboratories, Inc.
Decision Date1980-06-04
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 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 1980-06-04 under 510(k) number K801147. 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 PEDIATRIC ARTERIAL BLOOD FILTER #AF-5?

PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K801147.

When did PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 receive FDA 510(k) clearance?

PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801147.

Who is the listed applicant for PEDIATRIC ARTERIAL BLOOD FILTER #AF-5?

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 PEDIATRIC ARTERIAL BLOOD FILTER #AF-5?

The FDA product code for PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 is DTM.

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Other records listing Bentley Laboratories, Inc. as applicant

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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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