CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320— 510(k) K896973

Name: FDA 510(k) clearance K896973
Creator: U.S. Food and Drug Administration
Published: 1990-02-05

Substantially Equivalent

Daily Medical Products, Inc.

FDA 510(k) clearance K896973 for CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320, Substantially Equivalent on 1990-02-05. Applicant: Daily Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Daily Medical Products, Inc.
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 1989-12-13
Decision date: 1990-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWC

view all

K220635 — Heater-Cooler System 3T2022-11-16
K212657 — Quantum Heater-Cooler2022-05-06
K191402 — Heater-Cooler System 3T2020-02-25
K140012 — SORIN FLEXTHERM2014-01-31
K130300 — HEATER-COOLER UNIT HCU 402013-07-01

More clearances from Daily Medical Products, Inc.

view all

K914005 — FIBEROPTIC TYMPANIC THERMOMETER, MODEL 60001992-07-30
K905652 — MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-10001991-02-14
K905568 — TOPICAL COOLING PAD, MODEL 70001991-01-23
K896971 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-4201990-02-05
K896972 — CARDIAC COOLING JACKET, 12 CM, MODEL CJ-5201990-02-05

Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.