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subpart-f—cardiovascular-therapeutic-devices/

OPN NC PTCA Dilatation Catheter

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K212393
510(k) Type: Traditional
Applicant: SIS Medical AG
Country: Switzerland
FDA Decision: Substantially Equivalent
Decision Date: 3/14/2022
Days to Decision: 224 days
Submission Type: Summary

FDA Browser

subpart-f—cardiovascular-therapeutic-devices/

OPN NC PTCA Dilatation Catheter

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K212393
510(k) Type: Traditional
Applicant: SIS Medical AG
Country: Switzerland
FDA Decision: Substantially Equivalent
Decision Date: 3/14/2022
Days to Decision: 224 days
Submission Type: Summary