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FDA 510(k)

ARTERIAL BLOOD FILTER AF-1025-AF-1025BL

K-Number: K830131 · 1983-01-28

ApplicantAmerican Bentley
Decision Date1983-01-28
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTERIAL BLOOD FILTER AF-1025-AF-1025BL is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1983-01-28 under 510(k) number K830131. 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 AF-1025-AF-1025BL?

ARTERIAL BLOOD FILTER AF-1025-AF-1025BL is a medical device that received FDA 510(k) clearance on 1983-01-28. The listed applicant is American Bentley. The 510(k) number is K830131.

When did ARTERIAL BLOOD FILTER AF-1025-AF-1025BL receive FDA 510(k) clearance?

ARTERIAL BLOOD FILTER AF-1025-AF-1025BL received FDA 510(k) clearance on 1983-01-28, under 510(k) number K830131.

Who is the listed applicant for ARTERIAL BLOOD FILTER AF-1025-AF-1025BL?

The FDA 510(k) record lists American Bentley as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTERIAL BLOOD FILTER AF-1025-AF-1025BL?

The FDA product code for ARTERIAL BLOOD FILTER AF-1025-AF-1025BL is DTM.

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Other records listing American Bentley 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.

K872896UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100K873923INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERK870804CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100K872167CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500K872133OXYGENATOR MODEL NO. BENTLEY 5 PLUSK870911INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY

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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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