ENROUTE Transcarotid Neuroprotection System

Temporary Carotid Catheter For Embolic Capture

SILK ROAD MEDICAL, INC

The following data is part of a premarket notification filed by Silk Road Medical, Inc with the FDA for Enroute Transcarotid Neuroprotection System.

Pre-market Notification Details

Device IDK143072
510k NumberK143072
Device Name:ENROUTE Transcarotid Neuroprotection System
ClassificationTemporary Carotid Catheter For Embolic Capture
Applicant SILK ROAD MEDICAL, INC 735 NORTH PASTORIA AVE Sunnyvale,  CA  94085
ContactRichard M Ruedy
CorrespondentRichard M Ruedy
SILK ROAD MEDICAL, INC 735 NORTH PASTORIA AVE Sunnyvale,  CA  94085
Product CodeNTE  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-27
Decision Date2015-02-09
Summary:summary

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