SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT— 510(k) K964374

Substantially Equivalent

3M Healthcare

FDA 510(k) clearance K964374 for SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT, Substantially Equivalent on 1997-06-18. Applicant: 3M Healthcare.

Clearance details

Applicant: 3M Healthcare
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1996-11-01
Decision date: 1997-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, 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.