Home / 510(k) Clearances / K012743

510(k) K012743

TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T by Medtronic Perfusion Systems — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2001
Date Received
August 16, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
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)
  • K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE (March 19, 2013)
  • 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)

Other clearances for product code DRY

  • K234065 — CDI OneView Monitoring System (April 25, 2024)
  • K202154 — B-Capta (April 1, 2021)
  • K202557 — Quantum Workstation 12 Elite (October 2, 2020)
  • K182110 — CDI Blood Parameter Monitoring System 550 (November 2, 2018)
  • K181923 — Quantum Workstation 12.1 (August 17, 2018)
  • K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (March 28, 2018)
  • K163657 — Quantum Workstation (January 18, 2017)
  • K133157 — TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURF (October 23, 2014)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)