| 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 |