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EMBOGUARD Balloon Guide Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212340
510(k) Type
Traditional
Applicant
Neuravi Limited
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
12/17/2021
Days to Decision
142 days
Submission Type
Summary

EMBOGUARD Balloon Guide Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212340
510(k) Type
Traditional
Applicant
Neuravi Limited
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
12/17/2021
Days to Decision
142 days
Submission Type
Summary