QJP · Class II · 21 CFR 870.1250

FDA Product Code QJP: Catheter, Percutaneous, Neurovasculature

FDA product code QJP covers percutaneous catheters for access to the neurovasculature.

These highly specialized catheters are designed to navigate the tortuous anatomy of the cerebral arteries and veins for diagnostic angiography and the delivery of embolic agents, stents, and other interventional tools. They are used in the treatment of stroke, cerebral aneurysms, and arteriovenous malformations.

QJP devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Neurology panel.

Leading manufacturers include Stryker Neurovascular, Asahi Intecc Co., Ltd. and Penumbra, Inc..

20
Total
20
Cleared
188d
Avg days
2021
Since

List of Catheter, Percutaneous, Neurovasculature devices cleared through 510(k)

20 devices
1–20 of 20
Cleared Feb 11, 2026
AXS Lift Intracranial Base Catheter
K253032
Stryker Neurovascular
Neurology · 142d
Cleared Jun 20, 2025
Branchor X Balloon Guide Catheter
K251240
Asahi Intecc Co., Ltd.
Neurology · 59d
Cleared Jun 20, 2025
FUBUKI XF-R Neurovascular Long Sheath
K251560
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Mar 21, 2025
Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
K242289
Stryker Neurovascular
Neurology · 231d
Cleared Feb 18, 2025
AXS Lift Intracranial Base Catheter
K243593
Stryker Neurovascular
Neurology · 90d
Cleared Jan 02, 2025
Rist 079 Radial Access Guide Catheter
K241388
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 232d
Cleared Dec 19, 2024
Echo Intracranial Base Catheter
K241637
Stryker Neurovascular
Neurology · 195d
Cleared Dec 19, 2024
Broadway 8 Catheter
K241768
Stryker Neurovascular
Neurology · 182d
Cleared Dec 11, 2024
Access25™ Delivery Microcatheter
K242033
Penumbra, Inc.
Neurology · 153d
Cleared May 16, 2024
Wedge XL Delivery Catheter
K232542
MicroVention, Inc.
Neurology · 268d
Cleared Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201
Penumbra, Inc.
Neurology · 181d
Cleared Sep 14, 2023
SOFIA EX Intracranial Support Catheter
K230775
MicroVention, Inc.
Neurology · 177d
Cleared Nov 04, 2022
BENCHMARK BMX81 Access System
K221822
Penumbra, Inc.
Neurology · 134d
Cleared Oct 11, 2022
Branchor Balloon Guide Catheter
K221951
Asahi Intecc Co., Ltd.
Neurology · 98d
Cleared Aug 18, 2022
Benchmark BMX96 Access System
K213390
Penumbra, Inc.
Neurology · 307d
Cleared May 27, 2022
Benchmark Intracranial Access System
K212838
Penumbra, Inc.
Neurology · 262d
Cleared Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
K213589
Asahi Intecc Co., Ltd.
Neurology · 132d
Cleared Dec 10, 2021
Branchor Balloon Guide Catheter
K203723
Asahi Intecc Co., Ltd.
Neurology · 354d
Cleared Nov 26, 2021
Trevo Trak 21 Microcatheter
K211594
Stryker Neurovascular
Neurology · 186d
Cleared Aug 27, 2021
AXS Vecta 46 Intermediate Catheter
K202752
Stryker Neurovascular
Neurology · 340d

How to use this database

This page lists all FDA 510(k) submissions for Catheter, Percutaneous, Neurovasculature devices (product code QJP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Neurology FDA review panel. Browse all Neurology devices →