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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 K141118
Device Name NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
Applicant
Ev3, Inc.
3033 Campus Dr. Suite N 550
Plymouth,  MN  55441
Applicant Contact LAURA J LIND
Correspondent
Ev3, Inc.
3033 Campus Dr. Suite N 550
Plymouth,  MN  55441
Correspondent Contact LAURA J LIND
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/30/2014
Decision Date 07/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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