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) → QJP — Catheter, Percutaneous, Neurovasculature # QJP · Catheter, Percutaneous, Neurovasculature _Cardiovascular · 21 CFR 870.1250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP ## Overview - **Product Code:** QJP - **Device Name:** Catheter, Percutaneous, Neurovasculature - **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 88) Showing 20 most recent of 88 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K254223](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K254223.md) | Next Generation 088 Catheter | Balt USA, LLC | Apr 16, 2026 | SESE | | [K260938](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K260938.md) | PATH BGC | Crossroads Neurovascular, Inc. | Apr 15, 2026 | SESE | | [K253975](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K253975.md) | Radical 6F Access Catheter | Maduro Medical, Inc. | Apr 9, 2026 | SESE | | [K253032](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K253032.md) | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | Feb 11, 2026 | SESE | | [K252297](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K252297.md) | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | Jan 16, 2026 | SESE | | [K251097](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K251097.md) | V-DAC Catheter | Vesalio, Inc. | Jan 6, 2026 | SESE | | [K251668](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K251668.md) | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | Jan 5, 2026 | SESE | | [K252213](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K252213.md) | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | Dec 3, 2025 | SESE | | [K251372](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K251372.md) | VersaD Delivery Catheter | Unity Medical, Inc. | Oct 24, 2025 | SESE | | [K252569](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K252569.md) | Carrier XL Delivery Catheter | Balt USA, LLC | Oct 22, 2025 | SESE | | [K250960](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K250960.md) | DUO Microcatheter | Rev Neuro, LLC | Sep 8, 2025 | SESE | | [K251560](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K251560.md) | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | Jun 20, 2025 | SESE | | [K251240](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K251240.md) | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | Jun 20, 2025 | SESE | | [K251044](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K251044.md) | 93 NeuFlex Catheter | Piraeus Medical | May 23, 2025 | SESE | | [K242392](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K242392.md) | PATH BGC | Crossroads Neurovascular, Inc. | May 9, 2025 | SESE | | [K242289](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K242289.md) | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | Stryker Neurovascular | Mar 21, 2025 | SESE | | [K243593](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K243593.md) | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | Feb 18, 2025 | SESE | | [K242051](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K242051.md) | VersaD Delivery Catheter | Unity Medical, Inc. | Jan 17, 2025 | SESE | | [K243577](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K243577.md) | Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. | Jan 14, 2025 | SESE | | [K243297](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K243297.md) | APRO 70 Swift Catheter | Alembic, LLC | Jan 14, 2025 | SESE | ## Top Applicants - Stryker Neurovascular — 8 clearances - Route 92 Medical, Inc. — 6 clearances - Asahi Intecc Co., Ltd. — 5 clearances - Balt USA, LLC — 5 clearances - Imperative Care, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP) **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