FDA.reportPublic FDA data

510(k) K230402

Device
ENROUTE® Transcarotid Neuroprotection System
Applicant
Silk Road Medical
510(k) number
K230402
Product code
NTE
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-11
Date received
2023-02-15
Regulation
870.1250
Classification name
Temporary Carotid Catheter For Embolic Capture
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Denise Aycox
Address
1213 Innsbruck Dr. Sunnyvale CA US 94089 94089

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NTE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.2023-04-27
K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation2022-04-06
K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.2021-03-03
K200198WIRIONCardiovascular Systems, Inc.2020-03-18
K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular2019-07-25
K180023WIRIONGardia Medical , Ltd.2018-03-21
K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.2016-03-10
K153086RX ACCUNET Embolic Protection SystemAbbott Vascular2015-11-20
K143570WIRIONGardia Medical2015-06-04
K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.2015-02-09
K141678EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEMAbbott Vascular2014-07-22
K123156GORE FLOW REVERSAL SYSTEM MODEL GFRS073W. L. Gore & Associates, Inc.2012-12-13
K121015EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEMAbbott Vascular2012-05-04
K120480GORE(R) EMBOLIC FILTERW.L. Gore & Associates2012-03-16
K111010SPIDERFX EMBOLIC PROTECTION DEVICEEv3, Inc.2011-10-27