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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 K142565
Device Name Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter
Applicant
Stryker Neurovascular
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact Yoko Enrile
Correspondent
Stryker Neurovascular
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact Yoko Enrile
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/12/2014
Decision Date 11/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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