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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K190753
Device Name EverCrossTM 0.035 OTW PTA Dilatation Catheter
Applicant
Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.)
3033 Campus Drive, Suite N550
Plymouth,  MN  55441
Applicant Contact Breanna Fautsch
Correspondent
Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.)
3033 Campus Drive, Suite N550
Plymouth,  MN  55441
Correspondent Contact Breanna Fautsch
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received03/25/2019
Decision Date 04/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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