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510(k) K031544

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

K031544 is an FDA 510(k) premarket notification submitted by Jostra AB for the device "HEATER COOLER UNIT, MODEL HCU 30". The FDA issued a decision of Substantially Equivalent on August 7, 2003. The device falls under product code DWC (Controller, Temperature, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4250. Jostra AB has at least 10 other 510(k) clearances on record.

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)

FDA data resources