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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 K142654
Device Name Fortrex 0.035 OTW PTA Balloon Catheter
Applicant
Covidien, LLC
3033 Campus Dr.
Plymouth,  MN  55441
Applicant Contact Rupali Gupta
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
LIT  
Date Received09/18/2014
Decision Date 10/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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