ClearanceBrief
Panels › Cardiovascular › Product code NTE · Class 2

Temporary Carotid Catheter For Embolic Capture

Regulation 870.1250

0510(k)s in 12 months (36 all time)
2recalls in 12 months (30 all time)
30recalls that name a 510(k)
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Top companies in NTE

Company510(k)sRecalls
Cordis US Corp014
Boston Scientific Corp18
Abbott Vascular41
Guidant Corp.40
Medtronic, Inc.13
W. L. Gore & Associates, Inc.40
Cardiovascular Systems, Inc.21
Ev3, Inc.30
Medtronic Vascular, Inc.03
Silk Road Medical30
Decided510(k)Device and applicantCode
Apr 27, 2023K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
MicroVention, Inc.
NTE
Apr 11, 2023K230402ENROUTE® Transcarotid Neuroprotection System
Silk Road Medical
NTE
Apr 6, 2022K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
Cordis Corporation
NTE
Mar 3, 2021K210282WIRION Embolic Protection System
Cardiovascular Systems, Inc.
NTE
Mar 18, 2020K200198WIRION
Cardiovascular Systems, Inc.
NTE
Jul 25, 2019K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
Abbott Vascular
NTE
Mar 21, 2018K180023WIRION
Gardia Medical , Ltd., IL
NTE
Mar 10, 2016K153485ENROUTE Transcarotid Neuroprotection System
Silk Road Medical, Inc.
NTE
Nov 20, 2015K153086RX ACCUNET Embolic Protection System
Abbott Vascular
NTE
Jun 4, 2015K143570WIRION
Gardia Medical, IL
NTE
Feb 9, 2015K143072ENROUTE Transcarotid Neuroprotection System
Silk Road Medical, Inc.
NTE
Jul 22, 2014K141678EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Abbott Vascular
NTE
Dec 13, 2012K123156GORE FLOW REVERSAL SYSTEM MODEL GFRS073
W. L. Gore & Associates, Inc.
NTE
May 4, 2012K121015EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Abbott Vascular
NTE
Mar 16, 2012K120480GORE(R) EMBOLIC FILTER
W.L. Gore & Associates
NTE
Oct 27, 2011K111010SPIDERFX EMBOLIC PROTECTION DEVICE
Ev3, Inc.
NTE
Aug 17, 2011K111987FIBERNET EMBOLIC PROTECTION DEVICE
Lumen Biomedical, Inc.
NTE
May 23, 2011K103500GORE EMBOLIC FILTER
W. L. Gore & Associates, Inc.
NTE
Apr 29, 2011K110909EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
Abbott Laboratories
NTE
Jul 9, 2010K101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
Cordis Corp.
NTE
Oct 15, 2009K092177MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6
Invatec S.P.A.
NTE
May 22, 2009K090665EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
Abbott Vascular-Vascular Solutions
NTE
Feb 4, 2009K083300GORE FLOW REVERSAL SYSTEM
W. L. Gore & Associates, Inc.
NTE
Nov 18, 2008K082348FIBERNET EMBOLIC PROTECTION SYSTEM
Lumen Biomedical, Inc.
NTE
Sep 11, 2008K081523EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Abbott Vascular-Vascular Solutions
NTE
Aug 19, 2008K081549RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
Abbott Laboratories
NTE
Oct 31, 2007K072990GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
Medtronic, Inc.
NTE
Dec 5, 2006K063313FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
Boston Scientific Corp
NTE
Nov 14, 2006K063204SPIDERFX EMBOLIC PROTECTION DEVICE
Ev3, Inc.
NTE
Sep 22, 2006K062531ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
Cordis Corp., A Johnson & Johnson Co.
NTE
Feb 17, 2006K052659SPIDERX EMBOLIC PROTECTION DEVICE
Ev3, Inc.
NTE
Sep 14, 2005K052454THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
Abbott Vascular Devices
NTE
Aug 18, 2005K052166MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM
Guidant Corporation
NTE
Aug 16, 2005K052165RX ACCUNET EMBOLIC PROTECTION SYSTEM
Guidant Corporation
NTE
Nov 12, 2004K042908RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
Guidant Corp.
NTE
Aug 31, 2004K042218ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
Guidant Corp.
NTE

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