Sarns Warmer, Part #164975 and #164980

FDA 510(k) K873813 · 3M Health Care, Sarns

Substantially Equivalent

510(k) numberK873813

Submission

Device name
Sarns Warmer, Part #164975 and #164980
Applicant
3M Health Care, Sarns
Ann Arbor, MI, US
Received
September 18, 1987
Decision date
November 6, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DWC – Controller, Temperature, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4250
Specialty
Cardiovascular
Life-sustaining
Yes

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).

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K140012Sorin FlexthermDWC · Special Sorin Group Deutschland GmbH01/31/2014SE
K130300Heater-Cooler Unit Hcu 40DWC · Traditional Maquet Cardiopulmonary, AG07/01/2013SE
K122813Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional Cincinnati Sub-Zero Products, Inc.12/18/2012SE
K102147Cardioquip Modular Cooler-Heater Model MCH-1000DWC · Traditional Cardioquip Llp11/19/2010SE
K071521Terumo HX2 Temperature Management SystemDWC · Traditional Terumo Cardiovascular Systems Corp.11/21/2007SE
K052601Stockert Heater-Cooler System 3TDWC · Traditional Sorin Group Deutschland GmbH06/06/2006SE
K031544Heater Cooler Unit, Model Hcu 30DWC · Traditional Jostra AB08/07/2003SE

More from Jostra AB

510(k)DeviceDecision
K960916Sams 8000 Cardioplegia MonitorDSJ · Traditional 06/04/1996SE
K953901Sarns 800 Roller PumpDWB · Traditional 04/19/1996SE
K9507393M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemDWA · Traditional 11/17/1995SE
K941653Sarns Turbo Membrane Oxygenator ModificationDTZ · Traditional 08/24/1994SE
K941654Sarns Filtered Venous Reservior ModificationDTP · Traditional 07/26/1994SE
K940651Sarns Ultrasonic Air SensorKRL · Traditional 05/24/1994SE
K935391Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional 02/24/1994SE
K934127Sarns Low Jetting Aortic Arch CannulaDWF · Traditional 02/22/1994SE
K935977Sarns Air Detection SystemKRL · Traditional 02/04/1994SE
K915547Sarns 8000 Delphin II Centri Pump Mod W/Integr BatKFM · Traditional 09/09/1993SE

Questions and answers

When was Sarns Warmer, Part #164975 and #164980 cleared by the FDA?

Sarns Warmer, Part #164975 and #164980 (K873813) received a 510(k) decision of Substantially Equivalent on November 6, 1987, 49 days after the submission was received.

What is the product code of K873813?

The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.