E-VAX CHEST DRAINAGE SYSTEM— 510(k) K801043

Substantially Equivalent

Cardio Surgical Concepts, Inc.

FDA 510(k) clearance K801043 for E-VAX CHEST DRAINAGE SYSTEM, Substantially Equivalent on 1980-06-20. Applicant: Cardio Surgical Concepts, Inc..

Clearance details

Applicant: Cardio Surgical Concepts, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 1980-05-05
Decision date: 1980-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.