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..

89
Total
89
Cleared
162d
Avg days
2020
Since
89 devices
25–48 of 89
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 Sep 14, 2023
SOFIA EX Intracranial Support Catheter
K230775
MicroVention, Inc.
Neurology · 177d
Cleared Sep 13, 2023
NG Delivery Catheter
K230609
Balt USA, LLC
Neurology · 191d
Cleared Aug 15, 2023
Route 92 Medical Full Length 054 Access System
K231583
Route 92 Medical, Inc.
Neurology · 76d
Cleared May 22, 2023
TracStar LDP Large Distal Platform
K231168
Imperative Care, Inc.
Neurology · 27d
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