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FDA 510(k)

AFFINITY ARTERIAL BLOOD FILTER

K-Number: K952532 · 1995-10-06

ApplicantAvecor Cardiovascular, Inc.
Decision Date1995-10-06
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AFFINITY ARTERIAL BLOOD FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Avecor Cardiovascular, Inc.. It received FDA 510(k) clearance on 1995-10-06 under 510(k) number K952532. 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 AFFINITY ARTERIAL BLOOD FILTER?

AFFINITY ARTERIAL BLOOD FILTER is a medical device that received FDA 510(k) clearance on 1995-10-06. The listed applicant is Avecor Cardiovascular, Inc.. The 510(k) number is K952532.

When did AFFINITY ARTERIAL BLOOD FILTER receive FDA 510(k) clearance?

AFFINITY ARTERIAL BLOOD FILTER received FDA 510(k) clearance on 1995-10-06, under 510(k) number K952532.

Who is the listed applicant for AFFINITY ARTERIAL BLOOD FILTER?

The FDA 510(k) record lists Avecor Cardiovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFINITY ARTERIAL BLOOD FILTER?

The FDA product code for AFFINITY ARTERIAL BLOOD FILTER is DTM.

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Other records listing Avecor Cardiovascular, 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.

K973760AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACEK964017AFFINITY BLOOD PUMP SYSTEMK971105MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEMK940126AVECOR PRE-BYPASS FILTERK936003AFFINITY CVRK935717AFFINITY VENOUS RESERVIOR BAG

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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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