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, Route 92 Medical, Inc. and Asahi Intecc Co., Ltd..

91
Total
91
Cleared
163d
Avg days
2020
Since
91 devices
49–72 of 91
Cleared Sep 19, 2023
Millipede 088 Access Catheter
K231802
Perfuze, Ltd.
Neurology · 91d
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 21, 2023
Plato 17 Microcatheter
K223560
Scientia Vascular, Inc.
Neurology · 266d
Cleared Aug 15, 2023
Route 92 Medical Full Length 054 Access System
K231583
Route 92 Medical, Inc.
Neurology · 76d
Cleared Jun 22, 2023
SelectFlex Neurovascular Access System Family
K230322
Q'Apel Medical, Inc.
Neurology · 136d
Cleared May 22, 2023
TracStar LDP Large Distal Platform
K231168
Imperative Care, Inc.
Neurology · 27d
Cleared Mar 09, 2023
CEREGLIDE 71 Intermediate Catheter
K221930
Cerenovus, Inc.
Neurology · 251d
Cleared Dec 09, 2022
CELLO II Balloon Guide Catheter
K223275
Fuji Systems Corporation
Neurology · 46d
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 Oct 04, 2022
Route 92 Medical Full Length 070 Access System
K222743
Route 92 Medical, Inc.
Neurology · 25d
Cleared Sep 20, 2022
Millipede 088 Access Catheter
K214048
Perfuze, Ltd.
Neurology · 267d
Cleared Aug 18, 2022
Benchmark BMX96 Access System
K213390
Penumbra, Inc.
Neurology · 307d
Cleared Jun 02, 2022
Minjie Catheter System
K212288
Kai Medtech, LLC
Neurology · 316d
Cleared May 31, 2022
Distal Access Catheter
K213065
Guangzhou Easycess Medical Co.,Ltd
Neurology · 250d
Cleared May 27, 2022
Benchmark Intracranial Access System
K212838
Penumbra, Inc.
Neurology · 262d
Cleared May 17, 2022
Imperative Care Radial 088 Access System
K220807
Imperative Care, Inc.
Neurology · 60d
Cleared Apr 13, 2022
Bendit21 Microcatheter
K203842
Bend IT Technologies, Ltd.
Neurology · 468d
Cleared Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
K213589
Asahi Intecc Co., Ltd.
Neurology · 132d
Cleared Mar 15, 2022
CerusEndo Microcatheter (027)
K213314
Cerus Endovascular, Inc.
Neurology · 162d
Cleared Feb 10, 2022
Micro Catheter
K202926
Shanghai Heartcare Medical Technology Co., Ltd.
Neurology · 499d
Cleared Dec 17, 2021
EMBOGUARD Balloon Guide Catheter
K212340
Neuravi Limited
Neurology · 142d
Cleared Dec 16, 2021
MIVI Q Distal Access Catheter
K212402
Mivi Neuroscience, Inc.
Neurology · 136d