Sentry IVC Filter— 510(k) K181202

Substantially Equivalent

Novate Medical , Ltd.

FDA 510(k) clearance K181202 for Sentry IVC Filter, Substantially Equivalent on 2018-06-06. Applicant: Novate Medical , Ltd..

Clearance details

Applicant: Novate Medical , Ltd.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2018-05-07
Decision date: 2018-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

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.