| 2026-05-11 |
K254178 |
SAYA 86 Radial Access Guide Catheter |
QJP |
— |
— |
| 2026-02-02 |
K252011 |
CHIKAI Nexus petit |
MOF |
— |
— |
| 2025-06-20 |
K251560 |
FUBUKI XF-R Neurovascular Long Sheath |
QJP |
— |
— |
| 2025-06-20 |
K251240 |
Branchor X Balloon Guide Catheter |
QJP |
— |
— |
| 2025-04-21 |
K243383 |
CHIKAI Nexus 014 |
MOF |
— |
— |
| 2025-04-02 |
K243733 |
SION blue PLUS |
DQX |
Class II |
Cardiovascular |
| 2025-03-27 |
K241962 |
Crossloop |
DQX |
Class II |
Cardiovascular |
| 2025-03-05 |
K242597 |
CROSSLEAD 0.018inch |
DQX |
Class II |
Cardiovascular |
| 2025-02-06 |
K241702 |
CROSSLEAD 0.014inch |
DQX |
Class II |
Cardiovascular |
| 2024-12-17 |
K241801 |
Tornus ES |
FGE |
Class II |
Gastroenterology, Urology |
| 2024-08-14 |
K241510 |
CROSSLEAD Tracker |
DQX |
Class II |
Cardiovascular |
| 2024-06-25 |
K241158 |
ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 |
DQY |
— |
— |
| 2024-06-21 |
K240387 |
MINAMO blue; MINAMO viola |
DQX |
Class II |
Cardiovascular |
| 2023-07-20 |
K230377 |
CROSSLEAD Penetration Peripheral Guide Wire |
DQX |
Class II |
Cardiovascular |
| 2022-10-11 |
K221951 |
Branchor Balloon Guide Catheter |
QJP |
— |
— |
| 2022-09-06 |
K213868 |
ASAHI Gladius Mongo18 PV ES |
DQX |
Class II |
Cardiovascular |
| 2022-07-01 |
K213315 |
CROSSLEAD Peripheral Guide Wire |
DQX |
Class II |
Cardiovascular |
| 2022-03-24 |
K213589 |
FUBUKI XF Neurovascular Long Sheath |
QJP |
— |
— |
| 2021-12-10 |
K203723 |
Branchor Balloon Guide Catheter |
QJP |
— |
— |
| 2021-12-08 |
K211898 |
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 |
DQX |
Class II |
Cardiovascular |
| 2020-09-08 |
K202252 |
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), |
DQY |
— |
— |
| 2020-01-02 |
K192599 |
ASAHI PTCA Guide Wire ASAHI Gaia Next |
DQX |
Class II |
Cardiovascular |