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TubaVent Balloon Dilatation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223542
510(k) Type
Traditional
Applicant
Spiggle & Theis Medizintechnik GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
8/3/2023
Days to Decision
251 days
Submission Type
Summary

TubaVent Balloon Dilatation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223542
510(k) Type
Traditional
Applicant
Spiggle & Theis Medizintechnik GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
8/3/2023
Days to Decision
251 days
Submission Type
Summary