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510(k) K052601

STOCKERT HEATER-COOLER SYSTEM 3T by Sorin Group Deutschland GmbH — Product Code DWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2006
Date Received
September 21, 2005
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 Sorin Group Deutschland GmbH

  • K170460 — Sorin Connect (June 8, 2017)
  • K131553 — XTRA (March 21, 2014)
  • K140012 — SORIN FLEXTHERM (January 31, 2014)
  • K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEM (July 23, 2013)
  • K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5) (September 20, 2011)
  • K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (January 20, 2011)
  • K103762 — SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL W (January 20, 2011)
  • K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (January 18, 2011)
  • K103168 — B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) (January 6, 2011)
  • K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (December 9, 2010)

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)
  • K102147 — CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (November 19, 2010)
  • K071521 — TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (November 21, 2007)
  • K031544 — HEATER COOLER UNIT, MODEL HCU 30 (August 7, 2003)
  • K014016 — ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (February 1, 2002)