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510(k) K123351

AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE by Medtronic Perfusion Systems — Product Code DTM

K123351 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE". The FDA issued a decision of Substantially Equivalent on March 19, 2013. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2013
Date Received
October 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class
Class II
Regulation Number
870.4260
Review Panel
CV
Submission Type

Other clearances by Medtronic Perfusion Systems

  • K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac (July 10, 2024)
  • K181954 — autoLog IQ Autotransfusion System (August 22, 2018)
  • K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDI (September 3, 2010)
  • K090869 — MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE C (August 27, 2009)
  • K080824 — BIO-CONSOLE 560 (May 7, 2008)
  • K061254 — EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 (June 23, 2006)
  • K052524 — BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT (November 22, 2005)
  • K052372 — MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C (September 22, 2005)
  • K051303 — BIO-CONSOLE, MODEL 560 (June 10, 2005)
  • K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (May 24, 2005)

Other clearances for product code DTM

  • K251744 — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Ar (January 16, 2026)
  • K242953 — KIDS Arterial Filters (December 20, 2024)
  • K242092 — MICRO Arterial Filters (November 18, 2024)
  • K231362 — OCS Heart Leukocyte Depleting Filter (October 31, 2023)
  • K122760 — AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE (December 7, 2012)
  • K121209 — TERUMO PALL AL20X ARTERIAL FILTER (May 8, 2012)
  • K112525 — D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS (September 29, 2011)
  • K100646 — AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE (December 16, 2010)
  • K093986 — AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS (January 22, 2010)
  • K093601 — AF 840 PH.I.S.I.O. ARTERIAL FILTER (December 18, 2009)

FDA data resources