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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K202522
Device Name Synchro SELECT Guidewire
Applicant
Stryker Neurovascular
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact Hailey Hinkle
Correspondent
Stryker Neurovascular
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact Hailey Hinkle
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received09/01/2020
Decision Date 09/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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