SARNS EVACUPLEGE CATHETER— 510(k) K842044

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K842044 for SARNS EVACUPLEGE CATHETER, Substantially Equivalent on 1984-08-10. Applicant: 3M Health Care, Sarns.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 1984-05-21
Decision date: 1984-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.