Cardiac Cooling Jacked, 16 CM, Model CJ-620

Q: What is the product code of K896393?

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

FDA 510(k) K896393 · Daily Medical, Inc.

Substantially Equivalent

510(k) numberK896393

Submission

Device name: Cardiac Cooling Jacked, 16 CM, Model CJ-620
Applicant: Daily Medical, Inc.
San Diego, CA, US
Received: November 6, 1989
Decision date: February 2, 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)	Device	Applicant	Decision
K220635	Heater-Cooler System 3TDWC · Traditional	Livanova Deutschland, GmbH	11/16/2022SE
K212657	Quantum Heater-CoolerDWC · Traditional	Spectrum Medical , Ltd.	05/06/2022SE
K191402	Heater-Cooler System 3TDWC · Traditional	Livanova Deutschland, GmbH	02/25/2020SE
K140012	Sorin FlexthermDWC · Special	Sorin Group Deutschland GmbH	01/31/2014SE
K130300	Heater-Cooler Unit Hcu 40DWC · Traditional	Maquet Cardiopulmonary, AG	07/01/2013SE
K122813	Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional	Cincinnati Sub-Zero Products, Inc.	12/18/2012SE
K102147	Cardioquip Modular Cooler-Heater Model MCH-1000DWC · Traditional	Cardioquip Llp	11/19/2010SE
K071521	Terumo HX2 Temperature Management SystemDWC · Traditional	Terumo Cardiovascular Systems Corp.	11/21/2007SE
K052601	Stockert Heater-Cooler System 3TDWC · Traditional	Sorin Group Deutschland GmbH	06/06/2006SE
K031544	Heater Cooler Unit, Model Hcu 30DWC · Traditional	Jostra AB	08/07/2003SE

Questions and answers

When was Cardiac Cooling Jacked, 16 CM, Model CJ-620 cleared by the FDA?

Cardiac Cooling Jacked, 16 CM, Model CJ-620 (K896393) received a 510(k) decision of Substantially Equivalent on February 2, 1990, 88 days after the submission was received.

What is the product code of K896393?

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