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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 PARKWAY
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
Recalls CDRH Recalls
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