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..
102
Total
102
Cleared
162d
Avg days
2020
Since
102 devices
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
Cleared
Dec 10, 2021
Branchor Balloon Guide Catheter
Asahi Intecc Co., Ltd.
Neurology
354d
Cleared
Nov 26, 2021
Trevo Trak 21 Microcatheter
Stryker Neurovascular
Neurology
186d
Cleared
Nov 22, 2021
Spartan MC 0165
Spartan Micro
Neurology
27d
Cleared
Sep 20, 2021
TracStar LDP Large Distal Platform
Imperative Care, Inc.
Neurology
66d
Cleared
Aug 27, 2021
AXS Vecta 46 Intermediate Catheter
Stryker Neurovascular
Neurology
340d
Cleared
Aug 25, 2021
Balloon Guiding Catheter
Shanghai Heartcare Medical Technology Co., Ltd.
Neurology
330d
Cleared
Aug 05, 2021
SelectFlex Neurovascular Access System Family
Q'Apel Medical, Inc.
Neurology
45d
Cleared
Jul 27, 2021
Route 92 Medical Full Length 088 Access System
Route 92 Medical, Inc.
Neurology
146d
Cleared
Mar 03, 2021
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Imperative Care, Inc.
Neurology
70d
Cleared
Jan 28, 2021
BOSS 8F Balloon Guide Catheter
Marblehead Medical, LLC
Neurology
28d
Cleared
Nov 11, 2020
Route 92 Medical 070 Access System
Route 92 Medical, Inc.
Neurology
36d
Cleared
Sep 28, 2020
RIST Radial Access Catheter
Rist Neurovascular, Inc.
Neurology
98d
Cleared
Aug 14, 2020
Route 92 Medical 088 Access System
Route 92 Medical
Neurology
67d