WIRION— 510(k) K143570

Name: FDA 510(k) clearance K143570
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Substantially Equivalent

Gardia Medical

FDA 510(k) clearance K143570 for WIRION, Substantially Equivalent on 2015-06-04. Applicant: Gardia Medical. Device class: 2.

Clearance details

Applicant: Gardia Medical
Product code: Code NTE
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2014-12-17
Decision date: 2015-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

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K210282 — WIRION Embolic Protection System2021-03-03
K200198 — WIRION2020-03-18

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.