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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K113778
Device Name EXCELSIOR XT-27 MICROCATHETER
Applicant
Stryker Neurovascular
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact YOKO Y ENRILE
Correspondent
Dekra Certification B.V
Utrechtseweg 310
Arnhem,  NL NL-6812 AR
Correspondent Contact J.A. N VAN VUGT
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received12/22/2011
Decision Date 04/20/2012
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
Recalls CDRH Recalls
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