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FDA 510(k)

INTERFACE ARTERIAL BLOOD FILTER, MODEL 44

K-Number: K862609 · 1986-09-04

ApplicantMedical, Inc.
Decision Date1986-09-04
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 is the device name listed in this FDA 510(k) record. The listed applicant is Medical, Inc.. It received FDA 510(k) clearance on 1986-09-04 under 510(k) number K862609. 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 INTERFACE ARTERIAL BLOOD FILTER, MODEL 44?

INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 is a medical device that received FDA 510(k) clearance on 1986-09-04. The listed applicant is Medical, Inc.. The 510(k) number is K862609.

When did INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 receive FDA 510(k) clearance?

INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 received FDA 510(k) clearance on 1986-09-04, under 510(k) number K862609.

Who is the listed applicant for INTERFACE ARTERIAL BLOOD FILTER, MODEL 44?

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

What is the FDA product code for INTERFACE ARTERIAL BLOOD FILTER, MODEL 44?

The FDA product code for INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 is DTM.

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Other records listing Medical, 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.

K926454ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPONK894839OS-1 OCCLUSION SYSTEM - 1K872001MODEL TPC-1A OXYGEN ANALYZERK863806MODEL A-1 OXYGEN ANALYZERK862591INTERFACE ARTERIAL BLOOD FILTER, MODEL 42K861226INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70

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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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