NTE · Temporary Carotid Catheter For Embolic Capture
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | NTE |
|---|---|
| Device Name | Temporary Carotid Catheter For Embolic Capture |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | MicroVention, Inc. | Apr 27, 2023 | SESE |
| K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | Apr 11, 2023 | SESE |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | Cordis Corporation | Apr 6, 2022 | SESE |
| K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | Mar 3, 2021 | SESE |
| K200198 | WIRION | Cardiovascular Systems, Inc. | Mar 18, 2020 | SESE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | Abbott Vascular | Jul 25, 2019 | SESE |
| K180023 | WIRION | Gardia Medical , Ltd. | Mar 21, 2018 | SESE |
| K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | Mar 10, 2016 | SESE |
| K153086 | RX ACCUNET Embolic Protection System | Abbott Vascular | Nov 20, 2015 | SESE |
| K143570 | WIRION | Gardia Medical | Jun 4, 2015 | SESE |
| K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | Feb 9, 2015 | SESE |
| K141678 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | Jul 22, 2014 | SESE |
| K123156 | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 | W. L. Gore & Associates, Inc. | Dec 13, 2012 | SESE |
| K121015 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | May 4, 2012 | SESE |
| K120480 | GORE(R) EMBOLIC FILTER | W.L. Gore & Associates | Mar 16, 2012 | SESE |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | Oct 27, 2011 | SESE |
| K111987 | FIBERNET EMBOLIC PROTECTION DEVICE | Lumen Biomedical, Inc. | Aug 17, 2011 | SESE |
| K103500 | GORE EMBOLIC FILTER | W. L. Gore & Associates, Inc. | May 23, 2011 | SESE |
| K110909 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. | Abbott Laboratories | Apr 29, 2011 | SESE |
| K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Cordis Corp. | Jul 9, 2010 | SESE |
Top Applicants
- Abbott Vascular — 4 clearances
- Ev3, Inc. — 3 clearances
- W. L. Gore & Associates, Inc. — 3 clearances
- Abbott Laboratories — 2 clearances
- Abbott Vascular-Vascular Solutions — 2 clearances
