Synchro SELECT Guidewire

Guide, Wire, Catheter, Neurovasculature

STRYKER NEUROVASCULAR

The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Synchro Select Guidewire.

Pre-market Notification Details

Device IDK202522
510k NumberK202522
Device Name:Synchro SELECT Guidewire
ClassificationGuide, Wire, Catheter, Neurovasculature
Applicant STRYKER NEUROVASCULAR 47900 Bayside Parkway Fremont,  CA  94538
ContactHailey Hinkle
CorrespondentHailey Hinkle
STRYKER NEUROVASCULAR 47900 Bayside Parkway Fremont,  CA  94538
Product CodeMOF  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-01
Decision Date2020-09-25

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.