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Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202694
510(k) Type
Traditional
Applicant
Vycor Medical INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/14/2021
Days to Decision
120 days
Submission Type
Summary

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202694
510(k) Type
Traditional
Applicant
Vycor Medical INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/14/2021
Days to Decision
120 days
Submission Type
Summary