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
Cleared
Sep 19, 2023
Millipede 088 Access Catheter
Perfuze, Ltd.
Neurology
91d
Cleared
Sep 14, 2023
SOFIA EX Intracranial Support Catheter
MicroVention, Inc.
Neurology
177d
Cleared
Sep 13, 2023
NG Delivery Catheter
Balt USA, LLC
Neurology
191d
Cleared
Aug 21, 2023
Plato 17 Microcatheter
Scientia Vascular, Inc.
Neurology
266d
Cleared
Aug 15, 2023
Route 92 Medical Full Length 054 Access System
Route 92 Medical, Inc.
Neurology
76d
Cleared
Jun 22, 2023
SelectFlex Neurovascular Access System Family
Q'Apel Medical, Inc.
Neurology
136d
Cleared
May 22, 2023
TracStar LDP Large Distal Platform
Imperative Care, Inc.
Neurology
27d
Cleared
Mar 09, 2023
CEREGLIDE 71 Intermediate Catheter
Cerenovus, Inc.
Neurology
251d
Cleared
Dec 09, 2022
CELLO II Balloon Guide Catheter
Fuji Systems Corporation
Neurology
46d
Cleared
Nov 04, 2022
BENCHMARK BMX81 Access System
Penumbra, Inc.
Neurology
134d
Cleared
Oct 11, 2022
Branchor Balloon Guide Catheter
Asahi Intecc Co., Ltd.
Neurology
98d
Cleared
Oct 04, 2022
Route 92 Medical Full Length 070 Access System
Route 92 Medical, Inc.
Neurology
25d
Cleared
Sep 20, 2022
Millipede 088 Access Catheter
Perfuze, Ltd.
Neurology
267d
Cleared
Aug 18, 2022
Benchmark BMX96 Access System
Penumbra, Inc.
Neurology
307d
Cleared
Jun 02, 2022
Minjie Catheter System
Kai Medtech, LLC
Neurology
316d
Cleared
May 31, 2022
Distal Access Catheter
Guangzhou Easycess Medical Co.,Ltd
Neurology
250d
Cleared
May 27, 2022
Benchmark Intracranial Access System
Penumbra, Inc.
Neurology
262d
Cleared
May 17, 2022
Imperative Care Radial 088 Access System
Imperative Care, Inc.
Neurology
60d
Cleared
Apr 13, 2022
Bendit21 Microcatheter
Bend IT Technologies, Ltd.
Neurology
468d
Cleared
Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
Asahi Intecc Co., Ltd.
Neurology
132d
Cleared
Mar 15, 2022
CerusEndo Microcatheter (027)
Cerus Endovascular, Inc.
Neurology
162d
Cleared
Feb 10, 2022
Micro Catheter
Shanghai Heartcare Medical Technology Co., Ltd.
Neurology
499d
Cleared
Dec 17, 2021
EMBOGUARD Balloon Guide Catheter
Neuravi Limited
Neurology
142d
Cleared
Dec 16, 2021
MIVI Q Distal Access Catheter
Mivi Neuroscience, Inc.
Neurology
136d