QJP · Class II · 21 CFR 870.1250

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
73–91 of 91
Cleared Dec 10, 2021
Branchor Balloon Guide Catheter
K203723
Asahi Intecc Co., Ltd.
Neurology · 354d
Cleared Nov 26, 2021
Trevo Trak 21 Microcatheter
K211594
Stryker Neurovascular
Neurology · 186d
Cleared Nov 22, 2021
Spartan MC 0165
K213451
Spartan Micro
Neurology · 27d
Cleared Sep 20, 2021
TracStar LDP Large Distal Platform
K212224
Imperative Care, Inc.
Neurology · 66d
Cleared Aug 27, 2021
AXS Vecta 46 Intermediate Catheter
K202752
Stryker Neurovascular
Neurology · 340d
Cleared Aug 25, 2021
Balloon Guiding Catheter
K202916
Shanghai Heartcare Medical Technology Co., Ltd.
Neurology · 330d
Cleared Aug 05, 2021
SelectFlex Neurovascular Access System Family
K211893
Q'Apel Medical, Inc.
Neurology · 45d
Cleared Jul 27, 2021
Route 92 Medical Full Length 088 Access System
K210635
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
K203764
Imperative Care, Inc.
Neurology · 70d
Cleared Jan 28, 2021
BOSS 8F Balloon Guide Catheter
K203840
Marblehead Medical, LLC
Neurology · 28d
Cleared Nov 11, 2020
Route 92 Medical 070 Access System
K203043
Route 92 Medical, Inc.
Neurology · 36d
Cleared Sep 28, 2020
RIST Radial Access Catheter
K201682
Rist Neurovascular, Inc.
Neurology · 98d
Cleared Aug 14, 2020
Route 92 Medical 088 Access System
K201518
Route 92 Medical
Neurology · 67d
Cleared Aug 06, 2020
Anchor Dual Lumen Guidewire Catheter
K201076
Aqure Medical, Inc.
Neurology · 106d
Cleared May 02, 2020
RIST Radial Access Catheter
K200417
Rist Neurovascular, Inc.
Neurology · 72d
Cleared May 02, 2020
BOSS Balloon Guide Catheter
K200910
Marblehead Medical
Neurology · 26d
Cleared Apr 18, 2020
Route 92 Medical 088 Access System, 110 cm
K200121
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
K192804
Medos International SARL
Neurology · 149d
Cleared Feb 27, 2020
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
K200206
Stryker Neurovascular
Neurology · 30d