SIMON NITINOL FILTER SYSTEM— 510(k) K963016

Substantially Equivalent

Nitinol Medical Technologies, Inc.

FDA 510(k) clearance K963016 for SIMON NITINOL FILTER SYSTEM, Substantially Equivalent on 1996-11-18. Applicant: Nitinol Medical Technologies, Inc..

Clearance details

Applicant: Nitinol Medical Technologies, Inc.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 1996-08-02
Decision date: 1996-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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.