ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Silk Road Medical, Inc.

The following data is part of a premarket notification filed by Silk Road Medical, Inc. with the FDA for Enroute Enflate Transcarotid Rx Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK221414
510k NumberK221414
Device Name:ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Silk Road Medical, Inc. 1213 Innsbruck Drive Sunnyvale,  CA  94089
ContactDenise Aycox
CorrespondentDenise Aycox
Silk Road Medical, Inc. 1213 Innsbruck Drive Sunnyvale,  CA  94089
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-16
Decision Date2022-09-02

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