SOLITAIRE 2 REVASCULARIZATION DEVICE— 510(k) K123378

Name: FDA 510(k) clearance K123378
Creator: U.S. Food and Drug Administration
Published: 2012-11-30

Substantially Equivalent

Micro Therapeutics Dba Ev3 Neurovascular

FDA 510(k) clearance K123378 for SOLITAIRE 2 REVASCULARIZATION DEVICE, Substantially Equivalent on 2012-11-30. Applicant: Micro Therapeutics Dba Ev3 Neurovascular. Device class: 2.

Clearance details

Applicant: Micro Therapeutics Dba Ev3 Neurovascular
Product code: Code NRY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2012-11-01
Decision date: 2012-11-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.