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510(k) K945720

JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE by Jostra Bentley — Product Code DWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1995
Date Received
November 21, 1994
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 Bentley

  • K992559 — HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 (September 20, 1999)
  • K984338 — JOSTRA HL-20 TWIN PUMP (August 19, 1999)

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)
  • K031544 — HEATER COOLER UNIT, MODEL HCU 30 (August 7, 2003)