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Penumbra System (Reperfusion Catheter RED 43)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222808
510(k) Type
Traditional
Applicant
Penumbra, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/2022
Days to Decision
95 days
Submission Type
Summary

Penumbra System (Reperfusion Catheter RED 43)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222808
510(k) Type
Traditional
Applicant
Penumbra, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/2022
Days to Decision
95 days
Submission Type
Summary