510(k) K031544

HEATER COOLER UNIT, MODEL HCU 30 by Jostra AB — Product Code DWC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 7, 2003
Date Received: May 16, 2003
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 Jostra AB

K020983 — JOSTRA SUCKERS, MODEL JS (January 30, 2004)
K030264 — QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 (February 26, 2003)
K020784 — JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS (January 9, 2003)
K023132 — JOSTRA MECC SYSTEM (December 17, 2002)
K022022 — JOSTRA VENT CATHETERS, MODELS LV & HKV (September 11, 2002)
K020515 — JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA (April 24, 2002)
K014303 — JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (March 26, 2002)
K013944 — JOSTRA DUAL STAGE VENOUS RETURN CANNULAE (February 11, 2002)
K013939 — JOSTRA FLOWPROBE FP-32E (December 14, 2001)
K012774 — JOSTRA ARTERIAL PERFUSION CANNULAE (November 16, 2001)

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)
K052601 — STOCKERT HEATER-COOLER SYSTEM 3T (June 6, 2006)
K014016 — ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (February 1, 2002)