FDA Product Code
FDA Product Code NTE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | MicroVention, Inc. | 2023-04-27 | Traditional | PDF ↗ |
| K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023-04-11 | Special | PDF ↗ |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | Cordis Corporation | 2022-04-06 | Special | PDF ↗ |
| K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | 2021-03-03 | Special | PDF ↗ |
| K200198 | WIRION | Cardiovascular Systems, Inc. | 2020-03-18 | Traditional | PDF ↗ |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | Abbott Vascular | 2019-07-25 | Traditional | PDF ↗ |
| K180023 | WIRION | Gardia Medical , Ltd. | 2018-03-21 | Traditional | PDF ↗ |
| K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016-03-10 | Traditional | PDF ↗ |
| K153086 | RX ACCUNET Embolic Protection System | Abbott Vascular | 2015-11-20 | Special | PDF ↗ |
| K143570 | WIRION | Gardia Medical | 2015-06-04 | Traditional | PDF ↗ |
| K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015-02-09 | Traditional | PDF ↗ |
| K141678 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | 2014-07-22 | Special | PDF ↗ |
| K123156 | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 | W. L. Gore & Associates, Inc. | 2012-12-13 | Special | PDF ↗ |
| K121015 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | 2012-05-04 | Special | PDF ↗ |
| K120480 | GORE(R) EMBOLIC FILTER | W.L. Gore & Associates | 2012-03-16 | Special | PDF ↗ |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2011-10-27 | Traditional | PDF ↗ |
| K111987 | FIBERNET EMBOLIC PROTECTION DEVICE | Lumen Biomedical, Inc. | 2011-08-17 | Special | PDF ↗ |
| K103500 | GORE EMBOLIC FILTER | W. L. Gore & Associates, Inc. | 2011-05-23 | Traditional | PDF ↗ |
| K110909 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. | Abbott Laboratories | 2011-04-29 | Special | PDF ↗ |
| K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Cordis Corp. | 2010-07-09 | Special | PDF ↗ |
| K092177 | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 | Invatec S.P.A. | 2009-10-15 | Traditional | PDF ↗ |
| K090665 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 | Abbott Vascular-Vascular Solutions | 2009-05-22 | Special | PDF ↗ |
| K083300 | GORE FLOW REVERSAL SYSTEM | W. L. Gore & Associates, Inc. | 2009-02-04 | Traditional | PDF ↗ |
| K082348 | FIBERNET EMBOLIC PROTECTION SYSTEM | Lumen Biomedical, Inc. | 2008-11-18 | Traditional | PDF ↗ |
| K081523 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular-Vascular Solutions | 2008-09-11 | Traditional | PDF ↗ |
| K081549 | RX ACCUNET LP EMBOLIC PROTECTION SYSTEM | Abbott Laboratories | 2008-08-19 | Traditional | PDF ↗ |
| K072990 | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID | Medtronic, Inc. | 2007-10-31 | Traditional | PDF ↗ |
| K063313 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) | Boston Scientific Corp | 2006-12-05 | Traditional | PDF ↗ |
| K063204 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-11-14 | Special | PDF ↗ |
| K062531 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Cordis Corp., A Johnson & Johnson Co. | 2006-09-22 | Traditional | PDF ↗ |
| K052659 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-02-17 | Traditional | PDF ↗ |
| K052454 | THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM | Abbott Vascular Devices | 2005-09-14 | Traditional | PDF ↗ |
| K052166 | MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM | Guidant Corporation | 2005-08-18 | Special | PDF ↗ |
| K052165 | RX ACCUNET EMBOLIC PROTECTION SYSTEM | Guidant Corporation | 2005-08-16 | Special | PDF ↗ |
| K042908 | RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM | Guidant Corp. | 2004-11-12 | Special | PDF ↗ |
| K042218 | ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM | Guidant Corp. | 2004-08-31 | Traditional | PDF ↗ |
Product code NTE · Class II · Cardiovascular. Data: openFDA.