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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 K173515
Device Name Admiral Xtreme
Applicant
Medtronic Vascular
3576 Unoacal Pl.
Santa Rosa,  CA  95403
Applicant Contact Maddalena Pinsi
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 Received11/14/2017
Decision Date 04/12/2018
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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