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FDA 510(k)

CAPIOX AF125X ARTERIAL FILTER

K-Number: K052205 · 2005-09-12

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2005-09-12
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX AF125X 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 2005-09-12 under 510(k) number K052205. 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 CAPIOX AF125X ARTERIAL FILTER?

CAPIOX AF125X ARTERIAL FILTER is a medical device that received FDA 510(k) clearance on 2005-09-12. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K052205.

When did CAPIOX AF125X ARTERIAL FILTER receive FDA 510(k) clearance?

CAPIOX AF125X ARTERIAL FILTER received FDA 510(k) clearance on 2005-09-12, under 510(k) number K052205.

Who is the listed applicant for CAPIOX AF125X 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 CAPIOX AF125X ARTERIAL FILTER?

The FDA product code for CAPIOX AF125X ARTERIAL FILTER is DTM.

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Other records listing Terumo Cardiovascular Systems Corp. as applicant

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K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIRK130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHAK123039CDI BLOOD PARAMETER MONITORING SYSTEM 500K113214TLINK DATA MANAGEMENT SYSTEM (DMS)K112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,K092789VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

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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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