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Axium Prime Detachable Coil System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162704
510(k) Type
Traditional
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/2017
Days to Decision
97 days
Submission Type
Summary

Axium Prime Detachable Coil System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162704
510(k) Type
Traditional
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/2017
Days to Decision
97 days
Submission Type
Summary