QJP · Catheter, Percutaneous, Neurovasculature
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | QJP |
|---|---|
| Device Name | Catheter, Percutaneous, Neurovasculature |
| 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 88)
Showing 20 most recent of 88 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | Apr 16, 2026 | SESE |
| K260938 | PATH BGC | Crossroads Neurovascular, Inc. | Apr 15, 2026 | SESE |
| K253975 | Radical 6F Access Catheter | Maduro Medical, Inc. | Apr 9, 2026 | SESE |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | Feb 11, 2026 | SESE |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | Jan 16, 2026 | SESE |
| K251097 | V-DAC Catheter | Vesalio, Inc. | Jan 6, 2026 | SESE |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | Jan 5, 2026 | SESE |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | Dec 3, 2025 | SESE |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc. | Oct 24, 2025 | SESE |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | Oct 22, 2025 | SESE |
| K250960 | DUO Microcatheter | Rev Neuro, LLC | Sep 8, 2025 | SESE |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | Jun 20, 2025 | SESE |
| K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | Jun 20, 2025 | SESE |
| K251044 | 93 NeuFlex Catheter | Piraeus Medical | May 23, 2025 | SESE |
| K242392 | PATH BGC | Crossroads Neurovascular, Inc. | May 9, 2025 | SESE |
| K242289 | 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 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | Feb 18, 2025 | SESE |
| K242051 | VersaD Delivery Catheter | Unity Medical, Inc. | Jan 17, 2025 | SESE |
| K243577 | Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. | Jan 14, 2025 | SESE |
| K243297 | 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
