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SafeCross Vascular Introducer System (4001)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240600
510(k) Type
Special
Applicant
East End Medical I, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/6/2024
Days to Decision
186 days
Submission Type
Summary

SafeCross Vascular Introducer System (4001)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240600
510(k) Type
Special
Applicant
East End Medical I, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/6/2024
Days to Decision
186 days
Submission Type
Summary