Solitaire 2 Revascularization Device— 510(k) K162539

Substantially Equivalent

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

FDA 510(k) clearance K162539 for Solitaire 2 Revascularization Device, Substantially Equivalent on 2016-11-10. Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

Clearance details

Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code: Code POL
Advisory panel: Neurology
Date received: 2016-09-12
Decision date: 2016-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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