Bio-Cal 370 Heater/Cooler

• • Terminated Z-0900-2018 FDA Class II ·initiated 8 Feb 2018

  Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices.

510(k) Number

K894980 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bio Medicus Bio Pump Model Bp-80

  Class II

  FDA 510(k) K852698 Active Cleared 30 Sep 1985

• Urine Cultur Stabilization Transport Tube

  Class I

  FDA 510(k) K920761 Active Cleared 19 Jun 1992

• Cardiopulmonary Cannula Tubing

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  FDA 510(k) K861096 Active Cleared 21 May 1986

• Bio Pack Model 200

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  FDA 510(k) K853126 Active Cleared 11 Oct 1985

• Bio-Medicus Cannula Introducer

  Class II

  FDA 510(k) K903410 Active Cleared 31 Oct 1990

• Bio-Medicus Percutaneous Cannula & Introducer Set

  Class II

  FDA 510(k) K884129 Active Cleared 21 Dec 1988

See all devices from Bio Medicus, Inc. →