510(k) K122813

HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM by Cincinnati Sub-Zero Products, Inc. — Product Code DWC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 18, 2012
Date Received: September 13, 2012
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 Cincinnati Sub-Zero Products, Inc.

K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS (January 17, 2013)
K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) (July 3, 2012)
K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS (February 17, 2012)
K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM (February 4, 2011)
K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS (October 1, 2010)
K101589 — BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS (September 20, 2010)
K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE (December 13, 2007)
K070339 — DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES (September 26, 2007)
K942599 — WARM AIR WARMING UNIT (January 24, 1995)
K942790 — WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) (January 24, 1995)

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)
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)