ClearanceBrief
Panels › Cardiovascular › Product code QJP · Class 2

Catheter, Percutaneous, Neurovasculature

Regulation 870.1250

23510(k)s in 12 months (103 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in QJP

Company510(k)sRecalls
Stryker Neurovascular102
Route 92 Medical82
Asahi Intecc Co., Ltd.60
Balt USA, LLC60
Imperative Care, Inc.60
Penumbra, Inc.50
Perfuze, Ltd.50
Cerenovus, Inc.40
Maduro Medical, Inc.30
Piraeus Medical30
DateFirm and productCodeLinked 510(k)
Feb 26, 2025Scientia Vascular, Inc.
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interv
Open, Classified		 QJPK223560
Oct 7, 2024Stryker Neurovascular
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a h
Open, Classified		 QJPK211594
May 28, 2024Stryker Neurovascular
Trevo Trak 21 Microcatheter, Catalog: 90338
Open, Classified		 QJPK211594
Apr 24, 2024ROUTE 92 MEDICAL INC
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Open, Classified		 QJPK203043
Apr 24, 2024ROUTE 92 MEDICAL INC
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Open, Classified		 QJPK222743
Mar 13, 2024Medos International Sarl
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Open, Classified		 QJPK192804
Feb 14, 2024Stryker, Inc.
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Open, Classified		 QJPK211594

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