ECMO-TEMP (TM) BLOOD WARMING DEVICE— 510(k) K873699

Name: FDA 510(k) clearance K873699
Creator: U.S. Food and Drug Administration
Published: 1987-12-22

Substantially Equivalent

Seabrook Medical Systems, Inc.

FDA 510(k) clearance K873699 for ECMO-TEMP (TM) BLOOD WARMING DEVICE, Substantially Equivalent on 1987-12-22. Applicant: Seabrook Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Seabrook Medical Systems, Inc.
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 1987-09-16
Decision date: 1987-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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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.