Temporary Carotid Catheter For Embolic Capture
FDA product code NTE · Class II (moderate risk) · 21 CFR 870.1250 · Cardiovascular
This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i
36510(k) clearances
0PMA approvals
30recalls
Manufacturers
- Guidant Corp. 4
- W. L. Gore & Associates, Inc. 4
- Abbott Vascular 4
- Ev3, Inc. 3
- Silk Road Medical, Inc. 3
- Cardiovascular Systems, Inc. 2
- Gardia Medical 2
- Abbott Laboratories 2
- Abbott Vascular-Vascular Solutions 2
- Lumen Biomedical, Inc. 2
- Cordis Corp. 2
- MicroVention, Inc. 1
- Invatec S.P.A. 1
- Medtronic, Inc. 1
- Boston Scientific Corporation 1
- Cordis Corp., A Johnson & Johnson Co. 1
- Abbott Vascular Devices 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional | MicroVention, Inc. | 04/27/2023SE |
| K230402 | ENROUTE® Transcarotid Neuroprotection SystemNTE · Special | Silk Road Medical | 04/11/2023SE |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE · Special | Cordis Corporation | 04/06/2022SE |
| K210282 | WIRION Embolic Protection SystemNTE · Special | Cardiovascular Systems, Inc. | 03/03/2021SE |
| K200198 | WirionNTE · Traditional | Cardiovascular Systems, Inc. | 03/18/2020SE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | Abbott Vascular | 07/25/2019SE |
| K180023 | WirionNTE · Traditional | Gardia Medical , Ltd. | 03/21/2018SE |
| K153485 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 03/10/2016SE |
| K153086 | RX ACCUNET Embolic Protection SystemNTE · Special | Abbott Vascular | 11/20/2015SE |
| K143570 | WirionNTE · Traditional | Gardia Medical | 06/04/2015SE |
| K143072 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 02/09/2015SE |
| K141678 | Emboshield NAV6 Embolic Protection SystemNTE · Special | Abbott Vascular | 07/22/2014SE |
| K123156 | Gore Flow Reversal System Model GFRS073NTE · Special | W. L. Gore & Associates, Inc. | 12/13/2012SE |
| K121015 | Emboshield NAV6 Embolic Protection SystemNTE · Special | Abbott Vascular | 05/04/2012SE |
| K120480 | Gore(R) Embolic FilterNTE · Special | W.L. Gore & Associates | 03/16/2012SE |
| K111010 | Spiderfx Embolic Protection DeviceNTE · Traditional | Ev3, Inc. | 10/27/2011SE |
| K111987 | Fibernet Embolic Protection DeviceNTE · Special | Lumen Biomedical, Inc. | 08/17/2011SE |
| K103500 | Gore Embolic FilterNTE · Traditional | W. L. Gore & Associates, Inc. | 05/23/2011SE |
| K110909 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WIRE-WORKHORSE-190CM…NTE · Special | Abbott Laboratories | 04/29/2011SE |
| K101651 | Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture GuidewireNTE · Special | Cordis Corp. | 07/09/2010SE |
| K092177 | Mo.Ma Ultra Proximal Cerebral Protection Device, Model MUS0130069X6NTE · Traditional | Invatec S.P.A. | 10/15/2009SE |
| K090665 | Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19NTE · Special | Abbott Vascular-Vascular Solutions | 05/22/2009SE |
| K083300 | Gore Flow Reversal SystemNTE · Traditional | W. L. Gore & Associates, Inc. | 02/04/2009SE |
| K082348 | Fibernet Embolic Protection SystemNTE · Traditional | Lumen Biomedical, Inc. | 11/18/2008SE |
| K081523 | Emboshield NAV6 Embolic Protection SystemNTE · Traditional | Abbott Vascular-Vascular Solutions | 09/11/2008SE |
| K081549 | RX Accunet LP Embolic Protection SystemNTE · Traditional | Abbott Laboratories | 08/19/2008SE |
| K072990 | Guardwire Temporary Occlusion and Aspiration System- CarotidNTE · Traditional | Medtronic, Inc. | 10/31/2007SE |
| K063313 | Filterwire Ez Embolic Protection System (3.5 MM to 5.5 MM)NTE · Traditional | Boston Scientific Corp | 12/05/2006SE |
| K063204 | Spiderfx Embolic Protection DeviceNTE · Special | Ev3, Inc. | 11/14/2006SE |
| K062531 | Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli Capture GuidewireNTE · Traditional | Cordis Corp., A Johnson & Johnson Co. | 09/22/2006SE |
| K052659 | Spiderx Embolic Protection DeviceNTE · Traditional | Ev3, Inc. | 02/17/2006SE |
| K052454 | The Emboshield Embolic Protection SystemNTE · Traditional | Abbott Vascular Devices | 09/14/2005SE |
| K052166 | Modification to: RX Accunet Embolic Protection SystemNTE · Special | Guidant Corporation | 08/18/2005SE |
| K052165 | RX Accunet Embolic Protection SystemNTE · Special | Guidant Corporation | 08/16/2005SE |
| K042908 | RX Accunet 2 Embolic Protection SystemNTE · Special | Guidant Corp. | 11/12/2004SE |
| K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection SystemNTE · Traditional | Guidant Corp. | 08/31/2004SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2978-2026 Class I | Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number…Potential for arterial sheath tip separation or partial tip separation during use. | Boston Scientific Corporation | 07/09/2026Open, Classified |
| Z-2977-2026 Class I | Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number…Potential for arterial sheath tip separation or partial tip separation during use. | Boston Scientific Corporation | 07/09/2026Open, Classified |
| Z-0322-2024 Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each… | Medtronic Inc | 10/12/2023Open, Classified |
| Z-0321-2024 Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each… | Medtronic Inc | 10/12/2023Open, Classified |
| Z-0320-2024 Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each… | Medtronic Inc | 10/12/2023Open, Classified |
| Z-1496-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814REThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1495-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1494-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1493-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814REThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1492-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814REThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1491-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1490-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1489-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RECThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1488-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1487-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1486-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1485-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1484-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-1483-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | Cordis US Corp | 03/24/2023Open, Classified |
| Z-0394-2022 Class I | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter…Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such… | Cardiovascular Systems Inc | 11/22/2021Terminated |
| Z-1305-2014 Class II | FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum…Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS)… | Medtronic Vascular, Inc. | 03/03/2014Terminated |
| Z-1304-2014 Class II | FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum…Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS)… | Medtronic Vascular, Inc. | 03/03/2014Terminated |
| Z-1303-2014 Class II | FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum…Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS)… | Medtronic Vascular, Inc. | 03/03/2014Terminated |
| Z-0757-2013 Class II | Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part…The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet… | Abbott Vascular | 11/30/2011Terminated |
| Z-0110-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | Boston Scientific Corporation | 05/20/2008Terminated |
| Z-0109-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | Boston Scientific Corporation | 05/20/2008Terminated |
| Z-0108-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | Boston Scientific Corporation | 05/20/2008Terminated |
| Z-0107-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | Boston Scientific Corporation | 05/20/2008Terminated |
| Z-0106-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | Boston Scientific Corporation | 05/20/2008Terminated |
| Z-0105-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | Boston Scientific Corporation | 05/20/2008Terminated |