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510(k) K181954

autoLog IQ Autotransfusion System by Medtronic Perfusion Systems — Product Code CAC

K181954 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "autoLog IQ Autotransfusion System". The FDA issued a decision of Substantially Equivalent on August 22, 2018. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2018
Date Received
July 23, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
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)
  • 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)
  • K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (May 24, 2005)

Other clearances for product code CAC

  • K241236 — XTRA Collection sets; XTRA Sequestration set X (August 16, 2024)
  • K240426 — Aventus Clot Management System (May 14, 2024)
  • K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) (April 29, 2024)
  • K231782 — FlowSaver Blood Return System (80-101) (July 14, 2023)
  • K221483 — FlowSaver Blood Return System (February 17, 2023)
  • K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (November 15, 2022)
  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)

FDA data resources