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, Balt USA, LLC and Asahi Intecc Co., Ltd..

97
Total
97
Cleared
161d
Avg days
2020
Since
97 devices
25–48 of 97
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 17, 2025
VersaD Delivery Catheter
K242051
Unity Medical, Inc.
Neurology · 189d
Cleared Jan 14, 2025
APRO 70 Swift Catheter
K243297
Alembic, LLC
Neurology · 88d
Cleared Jan 14, 2025
Radical the Dude 8F Guide Catheter
K243577
Maduro Medical, Inc.
Neurology · 56d
Cleared Jan 02, 2025
Rist 079 Radial Access Guide Catheter
K241388
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 232d
Cleared Dec 30, 2024
Next Generation Access Platform
K242376
Balt USA, LLC
Neurology · 143d
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 Dec 06, 2024
87 NeuGlide Catheter
K240971
Piraeus Medical
Neurology · 241d
Cleared Dec 04, 2024
Socrates 38 Catheter
K242301
Scientia Vascular, Inc.
Neurology · 124d
Cleared Nov 20, 2024
Neurovascular Access System Family
K240746
Q'Apel Medical, Inc.
Neurology · 246d
Cleared Oct 17, 2024
Zipline Access Catheter
K240711
Perfuze, Ltd.
Neurology · 216d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241244
Cerenovus, Inc.
Neurology · 167d
Cleared Oct 02, 2024
8F Modified Sheath System
K240529
Route 92 Medical, Inc.
Neurology · 222d
Cleared Jul 02, 2024
Next Generation Access Catheter
K234074
Balt USA, LLC
Neurology · 193d
Cleared Jun 06, 2024
TracStar LDP Large Distal Platform
K240948
Imperative Care, Inc.
Neurology · 59d
Cleared May 16, 2024
Wedge XL Delivery Catheter
K232542
MicroVention, Inc.
Neurology · 268d
Cleared May 09, 2024
CEREGLIDE 92 Catheter System
K233982
Cerenovus, Inc.
Neurology · 143d
Cleared Apr 18, 2024
EMBOGUARD Balloon Guide Catheter
K233924
Neuravi Limited
Neurology · 127d
Cleared Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201
Penumbra, Inc.
Neurology · 181d
Cleared Mar 08, 2024
Esperance Distal Access Catheter
K231056
Wallaby Medical
Neurology · 330d
Cleared Jan 19, 2024
Distal Access Catheter
K231218
Accumedical Beijing , Ltd.
Neurology · 266d