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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 K132542
Device Name TRANSGATE GUIDE CATHETER
Applicant
Stryker Neurovascular
47900 Bayside Pkwy.
Freemont,  CA  94538
Applicant Contact ANJALI ATAL-GUPTA
Correspondent
Stryker Neurovascular
47900 Bayside Pkwy.
Freemont,  CA  94538
Correspondent Contact ANJALI ATAL-GUPTA
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/13/2013
Decision Date 11/15/2013
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
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