Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires— 510(k) K191173

Substantially Equivalent

Abbott Vascular

FDA 510(k) clearance K191173 for Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires, Substantially Equivalent on 2019-07-25. Applicant: Abbott Vascular.

Clearance details

Applicant: Abbott Vascular
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2019-05-01
Decision date: 2019-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NTE

product code NTE

Death: 28
Injury: 1,348
Malfunction: 771
Total: 2,147

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.