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FDA 510(k)

ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX

K-Number: K851003 · 1985-07-29

ApplicantGish Biomedical, Inc.
Decision Date1985-07-29
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1985-07-29 under 510(k) number K851003. 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 FILTER AFS-XX /FILTER HOLDER AFS-HXX?

ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K851003.

When did ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX receive FDA 510(k) clearance?

ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX received FDA 510(k) clearance on 1985-07-29, under 510(k) number K851003.

Who is the listed applicant for ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX?

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

What is the FDA product code for ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX?

The FDA product code for ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX is DTM.

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Other records listing Gish Biomedical, 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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