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FDA 510(k)

TERUMO PALL AL20X ARTERIAL FILTER

K-Number: K121209 · 2012-05-08

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2012-05-08
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO PALL AL20X ARTERIAL FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K121209. 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 AL20X ARTERIAL FILTER?

TERUMO PALL AL20X ARTERIAL FILTER is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K121209.

When did TERUMO PALL AL20X ARTERIAL FILTER receive FDA 510(k) clearance?

TERUMO PALL AL20X ARTERIAL FILTER received FDA 510(k) clearance on 2012-05-08, under 510(k) number K121209.

Who is the listed applicant for TERUMO PALL AL20X ARTERIAL FILTER?

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

What is the FDA product code for TERUMO PALL AL20X ARTERIAL FILTER?

The FDA product code for TERUMO PALL AL20X ARTERIAL FILTER is DTM.

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Other records listing Terumo Cardiovascular Systems Corporation 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.

K234065CDI OneView Monitoring SystemK221895Terumo Advanced Perfusion System 1K200091Capiox iCP Centrifugal PumpK182110CDI Blood Parameter Monitoring System 550K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)

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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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