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..
FDA 510(k) Cleared Catheter, Percutaneous, Neurovasculature Devices (Product Code QJP)
About Product Code QJP - Regulatory Context
510(k) Submission Activity
89 total 510(k) submissions under product code QJP since 2020, with 89 receiving FDA clearance (average review time: 162 days).
Submission volume has increased in recent years - 35 submissions in the last 24 months compared to 29 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for QJP submissions have been consistent, averaging 155 days recently vs 166 days historically.
QJP devices are reviewed by the Neurology panel. Browse all Neurology devices →