TUBING FOR CARDIOPULMONARY BYPASS— 510(k) K833112

Substantially Equivalent

Cardio Med Supplies, Inc.

FDA 510(k) clearance K833112 for TUBING FOR CARDIOPULMONARY BYPASS, Substantially Equivalent on 1983-11-28. Applicant: Cardio Med Supplies, Inc..

Clearance details

Applicant: Cardio Med Supplies, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1983-08-16
Decision date: 1983-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.