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Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181524
510(k) Type
Traditional
Applicant
Vyaire Medical, Inc.
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/30/2018
Days to Decision
172 days
Submission Type
Summary

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181524
510(k) Type
Traditional
Applicant
Vyaire Medical, Inc.
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/30/2018
Days to Decision
172 days
Submission Type
Summary