EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM— 510(k) K121015

Name: FDA 510(k) clearance K121015
Creator: U.S. Food and Drug Administration
Published: 2012-05-04

Substantially Equivalent

Abbott Vascular

FDA 510(k) clearance K121015 for EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, Substantially Equivalent on 2012-05-04. Applicant: Abbott Vascular. Device class: 2.

Clearance details

Applicant: Abbott Vascular
Product code: Code NTE
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2012-04-04
Decision date: 2012-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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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.