RX ACCUNET Embolic Protection System— 510(k) K153086

Name: FDA 510(k) clearance K153086
Creator: U.S. Food and Drug Administration
Published: 2015-11-20

Substantially Equivalent

Abbott Vascular

FDA 510(k) clearance K153086 for RX ACCUNET Embolic Protection System, Substantially Equivalent on 2015-11-20. 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: 2015-10-26
Decision date: 2015-11-20
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.