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Solitaire X Revascularization Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203358
510(k) Type
Traditional
Applicant
Micro Therapeutics, Inc d/b/a ev3 Neurovascular
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/1/2021
Days to Decision
105 days
Submission Type
Summary

Solitaire X Revascularization Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203358
510(k) Type
Traditional
Applicant
Micro Therapeutics, Inc d/b/a ev3 Neurovascular
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/1/2021
Days to Decision
105 days
Submission Type
Summary