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510(k) K102147

CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 by Cardioquip Llp — Product Code DWC

K102147 is an FDA 510(k) premarket notification submitted by Cardioquip Llp for the device "CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000". The FDA issued a decision of Substantially Equivalent on November 19, 2010. The device falls under product code DWC (Controller, Temperature, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2010
Date Received
July 30, 2010
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 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)
  • K130300 — HEATER-COOLER UNIT HCU 40 (July 1, 2013)
  • K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (December 18, 2012)
  • 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)

FDA data resources