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 Route 92 Medical, Inc..

91
Total
91
Cleared
163d
Avg days
2020
Since
91 devices
25–48 of 91
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
Cleared Dec 22, 2023
Distal Access Catheter
K233205
Shanghai Heartcare Medical Technology Co., Ltd.
Neurology · 85d
Cleared Dec 14, 2023
Millipede 088 Access Catheter
K233648
Perfuze, Ltd.
Neurology · 30d
Cleared Dec 01, 2023
Slinky Catheter
K231179
Anoxia Medical, Inc.
Neurology · 219d
Cleared Nov 30, 2023
Radical the Dude 7F Guide Catheter
K231393
Maduro Medical, Inc.
Neurology · 202d
Cleared Nov 29, 2023
CEREGLIDE 92 Intermediate Catheter
K230726
Cerenovus, Inc.
Neurology · 258d
Cleared Sep 19, 2023
Q Distal Access Catheter
K222948
Mivi Neuroscience, Inc.
Neurology · 357d