SIMON NITINOL FILTER— 510(k) K944353

Substantially Equivalent

Nitinol Medical Technologies, Inc.

FDA 510(k) clearance K944353 for SIMON NITINOL FILTER, Substantially Equivalent on 1995-04-28. Applicant: Nitinol Medical Technologies, Inc..

Clearance details

Applicant: Nitinol Medical Technologies, Inc.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 1994-08-30
Decision date: 1995-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.