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
Cleared
Dec 19, 2024
Broadway 8 Catheter
Stryker Neurovascular
Neurology
182d
Cleared
Dec 11, 2024
Access25™ Delivery Microcatheter
Penumbra, Inc.
Neurology
153d
Cleared
Dec 06, 2024
87 NeuGlide Catheter
Piraeus Medical
Neurology
241d
Cleared
Dec 04, 2024
Socrates 38 Catheter
Scientia Vascular, Inc.
Neurology
124d
Cleared
Nov 20, 2024
Neurovascular Access System Family
Q'Apel Medical, Inc.
Neurology
246d
Cleared
Oct 17, 2024
Zipline Access Catheter
Perfuze, Ltd.
Neurology
216d
Cleared
Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
Cerenovus, Inc.
Neurology
167d
Cleared
Oct 02, 2024
8F Modified Sheath System
Route 92 Medical, Inc.
Neurology
222d
Cleared
Jul 02, 2024
Next Generation Access Catheter
Balt USA, LLC
Neurology
193d
Cleared
Jun 06, 2024
TracStar LDP Large Distal Platform
Imperative Care, Inc.
Neurology
59d
Cleared
May 16, 2024
Wedge XL Delivery Catheter
MicroVention, Inc.
Neurology
268d
Cleared
May 09, 2024
CEREGLIDE 92 Catheter System
Cerenovus, Inc.
Neurology
143d
Cleared
Apr 18, 2024
EMBOGUARD Balloon Guide Catheter
Neuravi Limited
Neurology
127d
Cleared
Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
Penumbra, Inc.
Neurology
181d
Cleared
Mar 08, 2024
Esperance Distal Access Catheter
Wallaby Medical
Neurology
330d
Cleared
Jan 19, 2024
Distal Access Catheter
Accumedical Beijing , Ltd.
Neurology
266d
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 15, 2023
Route 92 Medical Full Length 054 Access System
Route 92 Medical, Inc.
Neurology
76d
Cleared
May 22, 2023
TracStar LDP Large Distal Platform
Imperative Care, Inc.
Neurology
27d
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
Aug 18, 2022
Benchmark BMX96 Access System
Penumbra, Inc.
Neurology
307d
Cleared
May 27, 2022
Benchmark Intracranial Access System
Penumbra, Inc.
Neurology
262d