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 Balt USA, LLC.
102
Total
102
Cleared
162d
Avg days
2020
Since
102 devices
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