SIMON NITINOL FILTER, MODIFICATION— 510(k) K912144

Substantially Equivalent

Nitinol Medical Technologies, Inc.

FDA 510(k) clearance K912144 for SIMON NITINOL FILTER, MODIFICATION, Substantially Equivalent on 1991-10-17. Applicant: Nitinol Medical Technologies, Inc..

Clearance details

Applicant: Nitinol Medical Technologies, Inc.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 1991-05-13
Decision date: 1991-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

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.