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AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163261
510(k) Type
Traditional
Applicant
ATRICURE INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/19/2017
Days to Decision
179 days
Submission Type
Summary

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163261
510(k) Type
Traditional
Applicant
ATRICURE INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/19/2017
Days to Decision
179 days
Submission Type
Summary