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Stone Retrieval Balloon Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210660
510(k) Type
Traditional
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/27/2021
Days to Decision
54 days
Submission Type
Summary

Stone Retrieval Balloon Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210660
510(k) Type
Traditional
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/27/2021
Days to Decision
54 days
Submission Type
Summary