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FDA 510(k)

TERUMO PALL AL3X ARTERIAL FILTER

K-Number: K083747 · 2009-08-20

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2009-08-20
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO PALL AL3X ARTERIAL FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2009-08-20 under 510(k) number K083747. 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 TERUMO PALL AL3X ARTERIAL FILTER?

TERUMO PALL AL3X ARTERIAL FILTER is a medical device that received FDA 510(k) clearance on 2009-08-20. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K083747.

When did TERUMO PALL AL3X ARTERIAL FILTER receive FDA 510(k) clearance?

TERUMO PALL AL3X ARTERIAL FILTER received FDA 510(k) clearance on 2009-08-20, under 510(k) number K083747.

Who is the listed applicant for TERUMO PALL AL3X ARTERIAL FILTER?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO PALL AL3X ARTERIAL FILTER?

The FDA product code for TERUMO PALL AL3X ARTERIAL FILTER is DTM.

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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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