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FDA 510(k) & PMA Approved Devices — 45 products

Total Devices45
Categories5
Latest FDA decision2026-05-11
TypeNumberDevice NameCodeDateActions
510(k) K254178 SAYA 86 Radial Access Guide CatheterQJP2026-05-11 View
510(k) K252011 CHIKAI Nexus petitMOF2026-02-02 View
510(k) K251240 Branchor X Balloon Guide CatheterQJP2025-06-20 View
510(k) K251560 FUBUKI XF-R Neurovascular Long SheathQJP2025-06-20 View
510(k) K243383 CHIKAI Nexus 014MOF2025-04-21 View
510(k) K243733 SION blue PLUSDQX2025-04-02 View
510(k) K241962 CrossloopDQX2025-03-27 View
510(k) K242597 CROSSLEAD 0.018inchDQX2025-03-05 View
510(k) K241702 CROSSLEAD 0.014inchDQX2025-02-06 View
510(k) K241801 Tornus ESFGE2024-12-17 View
510(k) K241510 CROSSLEAD TrackerDQX2024-08-14 View
510(k) K241158 ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3DQY2024-06-25 View
510(k) K240387 MINAMO blue; MINAMO violaDQX2024-06-21 View
510(k) K230377 CROSSLEAD Penetration Peripheral Guide WireDQX2023-07-20 View
510(k) K221951 Branchor Balloon Guide CatheterQJP2022-10-11 View
510(k) K213868 ASAHI Gladius Mongo18 PV ESDQX2022-09-06 View
510(k) K213315 CROSSLEAD Peripheral Guide WireDQX2022-07-01 View
510(k) K213589 FUBUKI XF Neurovascular Long SheathQJP2022-03-24 View
510(k) K203723 Branchor Balloon Guide CatheterQJP2021-12-10 View
510(k) K211898 ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20DQX2021-12-08 View

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