Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) → NTE — Temporary Carotid Catheter For Embolic Capture # NTE · Temporary Carotid Catheter For Embolic Capture _Cardiovascular · 21 CFR 870.1250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE ## Overview - **Product Code:** NTE - **Device Name:** Temporary Carotid Catheter For Embolic Capture - **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K222694.md) | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | MicroVention, Inc. | Apr 27, 2023 | SESE | | [K230402](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K230402.md) | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | Apr 11, 2023 | SESE | | [K220654](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K220654.md) | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | Cordis Corporation | Apr 6, 2022 | SESE | | [K210282](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K210282.md) | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | Mar 3, 2021 | SESE | | [K200198](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K200198.md) | WIRION | Cardiovascular Systems, Inc. | Mar 18, 2020 | SESE | | [K191173](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K191173.md) | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | Abbott Vascular | Jul 25, 2019 | SESE | | [K180023](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K180023.md) | WIRION | Gardia Medical , Ltd. | Mar 21, 2018 | SESE | | [K153485](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K153485.md) | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | Mar 10, 2016 | SESE | | [K153086](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K153086.md) | RX ACCUNET Embolic Protection System | Abbott Vascular | Nov 20, 2015 | SESE | | [K143570](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K143570.md) | WIRION | Gardia Medical | Jun 4, 2015 | SESE | | [K143072](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K143072.md) | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | Feb 9, 2015 | SESE | | [K141678](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K141678.md) | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | Jul 22, 2014 | SESE | | [K123156](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K123156.md) | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 | W. L. Gore & Associates, Inc. | Dec 13, 2012 | SESE | | [K121015](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K121015.md) | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | May 4, 2012 | SESE | | [K120480](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K120480.md) | GORE(R) EMBOLIC FILTER | W.L. Gore & Associates | Mar 16, 2012 | SESE | | [K111010](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K111010.md) | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | Oct 27, 2011 | SESE | | [K111987](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K111987.md) | FIBERNET EMBOLIC PROTECTION DEVICE | Lumen Biomedical, Inc. | Aug 17, 2011 | SESE | | [K103500](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K103500.md) | GORE EMBOLIC FILTER | W. L. Gore & Associates, Inc. | May 23, 2011 | SESE | | [K110909](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K110909.md) | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. | Abbott Laboratories | Apr 29, 2011 | SESE | | [K101651](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE/K101651.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NTE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com