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FDA 510(k)

GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)

K-Number: K862068 · 1986-08-08

ApplicantGelman Sciences, Inc.
Decision Date1986-08-08
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) 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 1986-08-08 under 510(k) number K862068. 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 GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)?

GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) is a medical device that received FDA 510(k) clearance on 1986-08-08. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K862068.

When did GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) receive FDA 510(k) clearance?

GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) received FDA 510(k) clearance on 1986-08-08, under 510(k) number K862068.

Who is the listed applicant for GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)?

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 GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)?

The FDA product code for GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) 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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