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510(k) K130300

HEATER-COOLER UNIT HCU 40 by Maquet Cardiopulmonary, AG — Product Code DWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2013
Date Received
February 7, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Temperature, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4250
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • K123288 — HEMOCONCENTRATOR (June 26, 2013)
  • K130639 — ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX (May 16, 2013)

Other clearances for product code DWC

  • K220635 — Heater-Cooler System 3T (November 16, 2022)
  • K212657 — Quantum Heater-Cooler (May 6, 2022)
  • K191402 — Heater-Cooler System 3T (February 25, 2020)
  • K140012 — SORIN FLEXTHERM (January 31, 2014)
  • K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (December 18, 2012)
  • K102147 — CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (November 19, 2010)
  • K071521 — TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (November 21, 2007)
  • K052601 — STOCKERT HEATER-COOLER SYSTEM 3T (June 6, 2006)
  • K031544 — HEATER COOLER UNIT, MODEL HCU 30 (August 7, 2003)
  • K014016 — ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (February 1, 2002)