Trevo Trak 21 Microcatheter

Catheter, Intravascular, Diagnostic

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Trevo Trak 21 Microcatheter.

Pre-market Notification Details

Device IDK192122
501k NumberK192122
Device Name:Trevo Trak 21 Microcatheter
ClassificationCatheter, Intravascular, Diagnostic
Applicant Stryker 47900 Bayside Parkway Fremont,  CA  94538
ContactRhoda Santos
CorrespondentRhoda Santos
Stryker 47900 Bayside Parkway Fremont,  CA  94538
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-06
Decision Date2019-11-22

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