Last synced on 1 March 2024 at 11:05 pm

Bearing nsPVA Express (S100EP); Bearing nsPVA Express (S200EP); Bearing nsPVA Express (S300EP); Bearing nsPVA Express (S400EP); Bearing nsPVA Express (S600EP); Bearing nsPVA Express (S800EP); Bearing nsPVA Express (S1100EP)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233813
510(k) Type
Special
Applicant
Merit Medical Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/21/2023
Days to Decision
21 days
Submission Type
Summary

Bearing nsPVA Express (S100EP); Bearing nsPVA Express (S200EP); Bearing nsPVA Express (S300EP); Bearing nsPVA Express (S400EP); Bearing nsPVA Express (S600EP); Bearing nsPVA Express (S800EP); Bearing nsPVA Express (S1100EP)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233813
510(k) Type
Special
Applicant
Merit Medical Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/21/2023
Days to Decision
21 days
Submission Type
Summary