FDA 510(k)

AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE

K-Number: K033468 · 2003-11-14

Decision Date2003-11-14

Product CodeDTM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Perfusion Systems. It received FDA 510(k) clearance on 2003-11-14 under 510(k) number K033468. 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 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE?

AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE is a medical device that received FDA 510(k) clearance on 2003-11-14. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K033468.

When did AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE receive FDA 510(k) clearance?

AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE received FDA 510(k) clearance on 2003-11-14, under 510(k) number K033468.

Who is the listed applicant for AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE?

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

What is the FDA product code for AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE?

The FDA product code for AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE is DTM.

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Other records listing Medtronic Perfusion Systems as applicant

K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)K181954autoLog IQ Autotransfusion System K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE K101186AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG K090869MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD K080824BIO-CONSOLE 560

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Related Devices (Code: DTM)

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronic K242953KIDS 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 Systems K122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.