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FDA 510(k)

MODIFIED GELMAN ARTERIAL FILTER

K-Number: K892387 · 1989-06-22

ApplicantGelman Sciences, Inc.
Decision Date1989-06-22
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED GELMAN ARTERIAL FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K892387. 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 MODIFIED GELMAN ARTERIAL FILTER?

MODIFIED GELMAN ARTERIAL FILTER is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K892387.

When did MODIFIED GELMAN ARTERIAL FILTER receive FDA 510(k) clearance?

MODIFIED GELMAN ARTERIAL FILTER received FDA 510(k) clearance on 1989-06-22, under 510(k) number K892387.

Who is the listed applicant for MODIFIED GELMAN ARTERIAL FILTER?

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

What is the FDA product code for MODIFIED GELMAN ARTERIAL FILTER?

The FDA product code for MODIFIED GELMAN ARTERIAL FILTER is DTM.

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Other records listing Gelman Sciences, 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.

K946190DRUG DISPENSING SPIKEK943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWN

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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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