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FDA 510(k)

TERUMO AL8X ARTERIAL FILTER WITH X-COATING

K-Number: K032128 · 2003-08-01

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2003-08-01
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO AL8X ARTERIAL FILTER WITH X-COATING 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 2003-08-01 under 510(k) number K032128. 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 AL8X ARTERIAL FILTER WITH X-COATING?

TERUMO AL8X ARTERIAL FILTER WITH X-COATING is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K032128.

When did TERUMO AL8X ARTERIAL FILTER WITH X-COATING receive FDA 510(k) clearance?

TERUMO AL8X ARTERIAL FILTER WITH X-COATING received FDA 510(k) clearance on 2003-08-01, under 510(k) number K032128.

Who is the listed applicant for TERUMO AL8X ARTERIAL FILTER WITH X-COATING?

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 AL8X ARTERIAL FILTER WITH X-COATING?

The FDA product code for TERUMO AL8X ARTERIAL FILTER WITH X-COATING is DTM.

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Other records listing Terumo Cardiovascular Systems Corp. 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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