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Balloon Guiding Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202916
510(k) Type
Traditional
Applicant
Shanghai Heartcare Medical Technology Co., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/25/2021
Days to Decision
330 days
Submission Type
Summary

Balloon Guiding Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202916
510(k) Type
Traditional
Applicant
Shanghai Heartcare Medical Technology Co., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/25/2021
Days to Decision
330 days
Submission Type
Summary