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510(k) K082544

QUART ARTERIAL FILTER WITH BIOLINE COATING by Maquet Cardiopulmonary, AG — Product Code DTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2008
Date Received
September 3, 2008
Clearance Type
Special
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 Maquet Cardiopulmonary, AG

  • K150267 — QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators (May 7, 2015)
  • K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) (November 19, 2014)
  • K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI (July 7, 2014)
  • K133598 — CARDIOHELP SYSTEM (May 21, 2014)
  • K133265 — QUADROX-IR ADULT AND SMALL ADULT (November 12, 2013)
  • K132166 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH (October 30, 2013)
  • K132829 — QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS (October 8, 2013)
  • K131666 — ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE CO (July 5, 2013)
  • K130300 — HEATER-COOLER UNIT HCU 40 (July 1, 2013)
  • K123288 — HEMOCONCENTRATOR (June 26, 2013)

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  • K242092 — MICRO Arterial Filters (November 18, 2024)
  • K231362 — OCS Heart Leukocyte Depleting Filter (October 31, 2023)
  • K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE (March 19, 2013)
  • 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)