Question 1

Who is the manufacturer of CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520?

Accepted Answer

Daily Medical Products, Inc. filed the 510(k) submission for CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 (K896972).

Question 2

What is the FDA product code for CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520?

Accepted Answer

DWC. It is classified under 21 CFR 870.4250 as a Class 2 device in the Cardiovascular panel.

Question 3

When was CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 cleared by the FDA?

Accepted Answer

Feb 5, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K896972
Device Name	CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
Applicant	Daily Medical Products, Inc.
Product Code	DWC · Cardiovascular
Decision Date	Feb 5, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4250
Device Class	Class 2

CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520

Device Facts

Regulatory Classification

Identification