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 |