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) → NRY — Catheter, Thrombus Retriever # NRY · Catheter, Thrombus Retriever _Cardiovascular · 21 CFR 870.1250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY ## Overview - **Product Code:** NRY - **Device Name:** Catheter, Thrombus Retriever - **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 106) Showing 20 most recent of 106 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253590](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K253590.md) | Millipede System | Perfuze, Ltd. | Mar 16, 2026 | SESE | | [K253062](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K253062.md) | Tigertriever 25 Revascularization Device | Rapid Medical , Ltd. | Mar 12, 2026 | SESE | | [K251357](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K251357.md) | Esperance pHLO Aspiration System | Phenox, Ltd. | Jan 15, 2026 | SESE | | [K251006](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K251006.md) | NeVasc Aspiration System | Vesalio, Inc. | Nov 10, 2025 | SESE | | [K252046](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K252046.md) | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | Oct 30, 2025 | SESE | | [K251603](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K251603.md) | Tigertriever 17 Ultra Revascularization Device | Rapid Medical , Ltd. | Oct 6, 2025 | SESE | | [K251789](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K251789.md) | EMBOTRAP III Revascularization Device | Neuravi Limited | Sep 25, 2025 | SESE | | [K252392](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K252392.md) | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | Aug 29, 2025 | SESE | | [K251828](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K251828.md) | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | Aug 22, 2025 | SESE | | [K243948](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K243948.md) | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | Jun 3, 2025 | SESE | | [K243047](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K243047.md) | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. | May 28, 2025 | SESE | | [K243601](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K243601.md) | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | May 19, 2025 | SESE | | [K251015](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K251015.md) | APRO 45 Catheter and Alembic Aspiration Tubing | Alembic, LLC | Apr 30, 2025 | SESE | | [K250958](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K250958.md) | APRO 55 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | Apr 28, 2025 | SESE | | [K250012](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K250012.md) | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | Feb 26, 2025 | SESE | | [K243287](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K243287.md) | APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | Feb 24, 2025 | SESE | | [K242104](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K242104.md) | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | Feb 13, 2025 | SESE | | [K242672](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K242672.md) | Zoom System | Imperative Care, Inc. | Jan 14, 2025 | SESE | | [K243080](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K243080.md) | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Oct 29, 2024 | SESE | | [K241221](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY/K241221.md) | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | Oct 16, 2024 | SESE | ## Top Applicants - Penumbra, Inc. — 24 clearances - Concentric Medical, Inc. — 16 clearances - Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — 11 clearances - Imperative Care, Inc. — 7 clearances - Alembic, LLC — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NRY) **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