Cardiac Cooling Jacket, 30% Reduced, Model CJ-220

FDA 510(k) K896975 · Daily Medical Products, Inc.

Substantially Equivalent

510(k) numberK896975

Submission

Device name
Cardiac Cooling Jacket, 30% Reduced, Model CJ-220
Applicant
Daily Medical Products, Inc.
San Diego, CA, US
Received
December 13, 1989
Decision date
February 5, 1990
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).

Other 510(k)s with product code DWC

510(k)DeviceApplicantDecision
K220635Heater-Cooler System 3TDWC · Traditional Livanova Deutschland, GmbH11/16/2022SE
K212657Quantum Heater-CoolerDWC · Traditional Spectrum Medical , Ltd.05/06/2022SE
K191402Heater-Cooler System 3TDWC · Traditional Livanova Deutschland, GmbH02/25/2020SE
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
K914005Fiberoptic Tympanic Thermometer, Model 6000FLL · Traditional 07/30/1992SE
K905652Myocardial Temperature Monitoring Probes, CJ-1000FLL · Traditional 02/14/1991SE
K905568Topical Cooling Pad, Model 7000DTR · Traditional 01/23/1991SE
K896974Cardiac Cooling Jacket, 8 CM, Model CJ-120DWC · Traditional 02/05/1990SE
K896973Cardiac Cooling Jacket, 30% Enlarged, Model CJ-320DWC · Traditional 02/05/1990SE
K896972Cardiac Cooling Jacket, 12 CM, Model CJ-520DWC · Traditional 02/05/1990SE
K896971Cardiac Cooling Jacket, 8 CM, Model CJ-420DWC · Traditional 02/05/1990SE

Questions and answers

When was Cardiac Cooling Jacket, 30% Reduced, Model CJ-220 cleared by the FDA?

Cardiac Cooling Jacket, 30% Reduced, Model CJ-220 (K896975) received a 510(k) decision of Substantially Equivalent on February 5, 1990, 54 days after the submission was received.

What is the product code of K896975?

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