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EverCrossTM 0.035 OTW PTA Dilatation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190753
510(k) Type
Special
Applicant
Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/23/2019
Days to Decision
29 days
Submission Type
Summary

EverCrossTM 0.035 OTW PTA Dilatation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190753
510(k) Type
Special
Applicant
Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/23/2019
Days to Decision
29 days
Submission Type
Summary