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
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
Cleared
Aug 06, 2020
Anchor Dual Lumen Guidewire Catheter
Aqure Medical, Inc.
Neurology
106d
Cleared
May 02, 2020
RIST Radial Access Catheter
Rist Neurovascular, Inc.
Neurology
72d
Cleared
May 02, 2020
BOSS Balloon Guide Catheter
Marblehead Medical
Neurology
26d
Cleared
Apr 18, 2020
Route 92 Medical 088 Access System, 110 cm
Route 92 Medical, Inc.
Neurology
88d
Cleared
Feb 27, 2020
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
Medos International SARL
Neurology
149d
Cleared
Feb 27, 2020
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
Stryker Neurovascular
Neurology
30d