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IntraClude Intra-Aortic Occlusion Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163693
510(k) Type
Special
Applicant
Edwards Lifesciences LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/26/2017
Days to Decision
29 days
Submission Type
Summary

IntraClude Intra-Aortic Occlusion Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163693
510(k) Type
Special
Applicant
Edwards Lifesciences LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/26/2017
Days to Decision
29 days
Submission Type
Summary