FDA 510(k) Applications for Medical Device Product Code "NTE"
(Temporary Carotid Catheter For Embolic Capture)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K110909 | ABBOTT LABORATORIES | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. | 04/29/2011 |
| K081549 | ABBOTT LABORATORIES | RX ACCUNET LP EMBOLIC PROTECTION SYSTEM | 08/19/2008 |
| K121015 | Abbott Vascular | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | 05/04/2012 |
| K141678 | Abbott Vascular | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | 07/22/2014 |
| K191173 | Abbott Vascular | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | 07/25/2019 |
| K153086 | ABBOTT VASCULAR | RX ACCUNET Embolic Protection System | 11/20/2015 |
| K052454 | ABBOTT VASCULAR DEVICES | THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM | 09/14/2005 |
| K081523 | ABBOTT VASCULAR-VASCULAR SOLUTIONS | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | 09/11/2008 |
| K090665 | ABBOTT VASCULAR-VASCULAR SOLUTIONS | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 | 05/22/2009 |
| K063313 | BOSTON SCIENTIFIC CORP. | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) | 12/05/2006 |
| K210282 | Cardiovascular Systems Inc. | WIRION Embolic Protection System | 03/03/2021 |
| K200198 | Cardiovascular Systems, Inc | WIRION | 03/18/2020 |
| K101651 | CORDIS CORP. | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | 07/09/2010 |
| K062531 | CORDIS CORP., A JOHNSON & JOHNSON CO. | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | 09/22/2006 |
| K220654 | Cordis Corporation | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | 04/06/2022 |
| K111010 | EV3 INC | SPIDERFX EMBOLIC PROTECTION DEVICE | 10/27/2011 |
| K063204 | EV3 INC | SPIDERFX EMBOLIC PROTECTION DEVICE | 11/14/2006 |
| K052659 | EV3 INC | SPIDERX EMBOLIC PROTECTION DEVICE | 02/17/2006 |
| K143570 | GARDIA MEDICAL | WIRION | 06/04/2015 |
| K180023 | Gardia Medical Ltd. | WIRION | 03/21/2018 |
| K042218 | GUIDANT CORP. | ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM | 08/31/2004 |
| K042908 | GUIDANT CORP. | RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM | 11/12/2004 |
| K052166 | GUIDANT CORPORATION | MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM | 08/18/2005 |
| K052165 | GUIDANT CORPORATION | RX ACCUNET EMBOLIC PROTECTION SYSTEM | 08/16/2005 |
| K092177 | INVATEC S.P.A. | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 | 10/15/2009 |
| K111987 | LUMEN BIOMEDICAL, INC. | FIBERNET EMBOLIC PROTECTION DEVICE | 08/17/2011 |
| K082348 | LUMEN BIOMEDICAL, INC. | FIBERNET EMBOLIC PROTECTION SYSTEM | 11/18/2008 |
| K072990 | MEDTRONIC INC. | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID | 10/31/2007 |
| K222694 | MicroVention, Inc. | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | 04/27/2023 |
| K230402 | Silk Road Medical | ENROUTE« Transcarotid Neuroprotection System | 04/11/2023 |
| K143072 | SILK ROAD MEDICAL, INC | ENROUTE Transcarotid Neuroprotection System | 02/09/2015 |
| K153485 | SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Neuroprotection System | 03/10/2016 |
| K123156 | W. L. GORE & ASSOCIATES, INC. | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 | 12/13/2012 |
| K120480 | W.L. GORE & ASSOCIATES | GORE(R) EMBOLIC FILTER | 03/16/2012 |
| K103500 | W.L. GORE & ASSOCIATES,INC | GORE EMBOLIC FILTER | 05/23/2011 |
| K083300 | W.L. GORE & ASSOCIATES,INC | GORE FLOW REVERSAL SYSTEM | 02/04/2009 |
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