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Distal Access Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233205
510(k) Type
Traditional
Applicant
Shanghai HeartCare Medical Technology Co.,Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/22/2023
Days to Decision
85 days
Submission Type
Summary

Distal Access Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233205
510(k) Type
Traditional
Applicant
Shanghai HeartCare Medical Technology Co.,Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/22/2023
Days to Decision
85 days
Submission Type
Summary