Last synced on 25 November 2022 at 11:04 pm

Balloon Dilatation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213578
510(k) Type
Traditional
Applicant
Hangzhou AGS MedTech Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/6/2022
Days to Decision
147 days
Submission Type
Summary

Balloon Dilatation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213578
510(k) Type
Traditional
Applicant
Hangzhou AGS MedTech Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/6/2022
Days to Decision
147 days
Submission Type
Summary