Solitaire 2 and Solitaire Platinum Revascularization Device— 510(k) K181060

Name: FDA 510(k) clearance K181060
Creator: U.S. Food and Drug Administration
Published: 2018-08-24

Substantially Equivalent

Medtronic Neurovascular

FDA 510(k) clearance K181060 for Solitaire 2 and Solitaire Platinum Revascularization Device, Substantially Equivalent on 2018-08-24. Applicant: Medtronic Neurovascular. Device class: 2.

Clearance details

Applicant: Medtronic Neurovascular
Product code: Code POL
Device class: Class 2
Regulation: 21 CFR 882.5600
Advisory panel: Neurology
Date received: 2018-04-23
Decision date: 2018-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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