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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K172315
Device Name Straub Endovascular System
Applicant
Straub Medical AG
Straubstrasse 12
Wangs,  CH ch 7323
Applicant Contact Amy Ehlenfeldt
Correspondent
NAMSA
400 Hwy 169 South
Suite 500
Minneapolis,  MN  55426
Correspondent Contact Barbara Atzenhoefer
Regulation Number870.4875
Classification Product Code
MCW  
Subsequent Product Code
QEW  
Date Received08/01/2017
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 No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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