FDA 510(k) Applications for Medical Device Product Code "QJP"

FDA 510(k) Number Applicant Device Name Decision Date
K201076 Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter 08/06/2020
K203723 Asahi Intecc Co., Ltd Branchor Balloon Guide Catheter 12/10/2021
K221951 Asahi Intecc Co., Ltd Branchor Balloon Guide Catheter 10/11/2022
K213589 Asahi Intecc Co., Ltd. FUBUKI XF Neurovascular Long Sheath 03/24/2022
K230609 Balt USA, LLC NG Delivery Catheter 09/13/2023
K203842 Bend It Technologies Ltd Bendit21 Microcatheter 04/13/2022
K221930 Cerenovus, Inc. CEREGLIDE 71 Intermediate Catheter 03/09/2023
K213314 Cerus Endovascular, Inc. CerusEndo Microcatheter (027) 03/15/2022
K223275 Fuji Systems Corporation CELLO II Balloon Guide Catheter 12/09/2022
K213065 Guangzhou Easycess Medical Co., Ltd Distal Access Catheter 05/31/2022
K220807 Imperative Care Inc. Imperative Care Radial 088 Access System 05/17/2022
K203764 Imperative Care Inc. TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform 03/03/2021
K212224 Imperative Care Inc. TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform 09/20/2021
K231168 Imperative Care Inc. TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support 05/22/2023
K212288 Kai Medtech, LLC Minjie Catheter System 06/02/2022
K200910 Marblehead Medical BOSS Balloon Guide Catheter 05/02/2020
K203840 Marblehead Medical LLC BOSS 8F Balloon Guide Catheter 01/28/2021
K192804 Medos International SARL CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm 02/27/2020
K230775 MicroVention, Inc. SOFIA EX Intracranial Support Catheter 09/14/2023
K222948 MIVI Neuroscience, Inc Q Distal Access Catheter 09/19/2023
K212402 MIVI Neuroscience, Inc. MIVI Q Distal Access Catheter 12/16/2021
K212340 Neuravi Limited EMBOGUARD Balloon Guide Catheter 12/17/2021
K221822 Penumbra, Inc BENCHMARK BMX81 Access System 11/04/2022
K213390 Penumbra, Inc. Benchmark BMX96 Access System 08/18/2022
K212838 Penumbra, Inc. Benchmark Intracranial Access System 05/27/2022
K231802 Perfuze Ltd. Millipede 088 Access Catheter 09/19/2023
K214048 Perfuze Ltd. Millipede 088 Access Catheter 09/20/2022
K211893 Q'Apel Medical Inc SelectFlex Neurovascular Access System Family 08/05/2021
K230322 Q'apel Medical, Inc. SelectFlex Neurovascular Access System Family 06/22/2023
K200417 RIST Neurovascular, Inc. RIST Radial Access Catheter 05/02/2020
K201682 RIST Neurovascular, Inc. RIST Radial Access Catheter 09/28/2020
K201518 Route 92 Medical Route 92 Medical 088 Access System 08/14/2020
K200121 Route 92 Medical Inc. Route 92 Medical 088 Access System, 110 cm 04/18/2020
K210635 Route 92 Medical Inc. Route 92 Medical Full Length 088 Access System 07/27/2021
K203043 Route 92 Medical, Inc. Route 92 Medical 070 Access System 11/11/2020
K231583 Route 92 Medical, Inc. Route 92 Medical Full Length 054 Access System 08/15/2023
K222743 Route 92 Medical, Inc. Route 92 Medical Full Length 070 Access System 10/04/2022
K223560 Scientia Vascular Inc Plato 17 Microcatheter 08/21/2023
K202916 Shanghai Heartcare Medical Technology Co., Ltd Balloon Guiding Catheter 08/25/2021
K202926 Shanghai Heartcare Medical Technology Co., Ltd. Micro Catheter 02/10/2022
K213451 Spartan Micro Spartan MC 0165 11/22/2021
K202752 Stryker Neurovascular AXS Vecta 46 Intermediate Catheter 08/27/2021
K200206 Stryker Neurovascular AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter 02/27/2020
K211594 Stryker Neurovascular Trevo Trak 21 Microcatheter 11/26/2021


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