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

FDA 510(k) Number Applicant Device Name Decision Date
K231218 AccuMedical Beijing Ltd. Distal Access Catheter 01/19/2024
K243297 Alembic, LLC APRO 70 Swift Catheter 01/14/2025
K231179 Anoxia Medical, Inc. Slinky Catheter 12/01/2023
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
K251240 Asahi Intecc Co., Ltd. Branchor X Balloon Guide Catheter 06/20/2025
K213589 Asahi Intecc Co., Ltd. FUBUKI XF Neurovascular Long Sheath 03/24/2022
K251560 Asahi Intecc Co., Ltd. FUBUKI XF-R Neurovascular Long Sheath 06/20/2025
K234074 Balt USA, LLC Next Generation Access Catheter 07/02/2024
K242376 Balt USA, LLC Next Generation Access Platform 12/30/2024
K230609 Balt USA, LLC NG Delivery Catheter 09/13/2023
K203842 Bend It Technologies Ltd Bendit21 Microcatheter 04/13/2022
K233982 Cerenovus Inc. CEREGLIDE 92 Catheter System 05/09/2024
K241244 Cerenovus, Inc. CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter 10/16/2024
K221930 Cerenovus, Inc. CEREGLIDE 71 Intermediate Catheter 03/09/2023
K230726 Cerenovus, Inc. CEREGLIDE 92 Intermediate Catheter 11/29/2023
K213314 Cerus Endovascular, Inc. CerusEndo Microcatheter (027) 03/15/2022
K242392 Crossroads Neurovascular, Inc. PATH BGC 05/09/2025
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
K240948 Imperative Care, Inc. TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support 06/06/2024
K212288 Kai Medtech, LLC Minjie Catheter System 06/02/2022
K231393 Maduro Medical, Inc. Radical the Dude 7F Guide Catheter 11/30/2023
K243577 Maduro Medical, Inc. Radical the Dude 8F Guide Catheter 01/14/2025
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
K241388 Micro Therapeutics Inc. d/b/a ev3 Neurovascular Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter 01/02/2025
K230775 MicroVention, Inc. SOFIA EX Intracranial Support Catheter 09/14/2023
K232542 MicroVention, Inc. Wedge XL Delivery Catheter 05/16/2024
K222948 MIVI Neuroscience, Inc Q Distal Access Catheter 09/19/2023
K212402 MIVI Neuroscience, Inc. MIVI Q Distal Access Catheter 12/16/2021
K233924 Neuravi Limited EMBOGUARD Balloon Guide Catheter 04/18/2024
K212340 Neuravi Limited EMBOGUARD Balloon Guide Catheter 12/17/2021
K221822 Penumbra, Inc BENCHMARK BMX81 Access System 11/04/2022
K242033 Penumbra, Inc. Access25Ö Delivery Microcatheter 12/11/2024
K213390 Penumbra, Inc. Benchmark BMX96 Access System 08/18/2022
K212838 Penumbra, Inc. Benchmark Intracranial Access System 05/27/2022
K233201 Penumbra, Inc. MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) 03/27/2024
K231802 Perfuze Ltd. Millipede 088 Access Catheter 09/19/2023
K233648 Perfuze Ltd. Millipede 088 Access Catheter 12/14/2023
K214048 Perfuze Ltd. Millipede 088 Access Catheter 09/20/2022
K240711 Perfuze Ltd. Zipline Access Catheter 10/17/2024
K240971 Piraeus Medical 87 NeuGlide Catheter 12/06/2024
K251044 Piraeus Medical 93 NeuFlex Catheter 05/23/2025
K211893 Q'Apel Medical Inc SelectFlex Neurovascular Access System Family 08/05/2021
K240746 Q'Apel Medical, Inc. Neurovascular Access System Family 11/20/2024
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
K240529 Route 92 Medical, Inc. 8F Modified Sheath System 10/02/2024
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
K242301 Scientia Vascular Inc Socrates 38 Catheter 12/04/2024
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
K233205 Shanghai HeartCare Medical Technology Co.,Ltd. Distal Access Catheter 12/22/2023
K213451 Spartan Micro Spartan MC 0165 11/22/2021
K243593 Stryker Neurovascular AXS Lift Intracranial Base Catheter 02/18/2025
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
K241768 Stryker Neurovascular Broadway 8 Catheter 12/19/2024
K241637 Stryker Neurovascular Echo Intracranial Base Catheter 12/19/2024
K242289 Stryker Neurovascular Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter 03/21/2025
K211594 Stryker Neurovascular Trevo Trak 21 Microcatheter 11/26/2021
K242051 Unity Medical, Inc. VersaD Delivery Catheter 01/17/2025
K231056 Wallaby Medical Esperance Distal Access Catheter 03/08/2024


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