InZone Detachment System

Device, Neurovascular Embolization

STRYKER NEUROVASCULAR

The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Inzone Detachment System.

Pre-market Notification Details

Device IDK160096
510k NumberK160096
Device Name:InZone Detachment System
ClassificationDevice, Neurovascular Embolization
Applicant STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont,  CA  94538 -6515
ContactKate Taylor
CorrespondentKate Taylor
STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont,  CA  94538 -6515
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-19
Decision Date2016-02-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.