AXS Vecta Aspiration System

Catheter, Thrombus Retriever

Stryker Neurovascular

The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Axs Vecta Aspiration System.

Pre-market Notification Details

Device IDK191768
510k NumberK191768
Device Name:AXS Vecta Aspiration System
ClassificationCatheter, Thrombus Retriever
Applicant Stryker Neurovascular 47900 Bayside Parkway Fremont,  CA  94538
ContactShazia Hakim
CorrespondentShazia Hakim
Stryker Neurovascular 47900 Bayside Parkway Fremont,  CA  94538
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-01
Decision Date2019-07-30
Summary:summary

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