Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

Penumbra, Inc.

FDA 510(k) & PMA Approved Dispositivos — 60 products

Total de dispositivos60
Categorías0
Última decisión de la FDA
TipoNúmeroNombre del dispositivoCódigoFechaAcciones
510(k) K250690 Penumbra System (Thunderbolt Aspiration Tubing)NRY2026-06-10 Ver
510(k) K260599 INDIGO® Aspiration System – INDIGO LinkQEW2026-04-24 Ver
510(k) K251949 INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW2026-02-05 Ver
510(k) K252612 INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingQEW2025-10-16 Ver
510(k) K250079 Ruby XL SystemKRD2025-03-14 Ver
510(k) K242104 Penumbra System (Reperfusion Catheter RED 72)NRY2025-02-13 Ver
510(k) K242033 Access25® Catéter de Microcatheter para EntregaQJP2024-12-11 Ver
510(k) K242520 Element Vascular Access SystemDYB2024-11-20 Ver
510(k) K242075 Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2024-09-25 Ver
510(k) K242319 Indigo® Aspiration System – Aspiration Catheter 6XQEW2024-09-03 Ver
510(k) K241399 Indigo® Lightning Flash Aspiration System – Select +™ CatheterQEW2024-06-10 Ver
510(k) K233201 MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)QJP2024-03-27 Ver
510(k) K240030 Indigo® Aspiration System - Lightning® FlashQEW2024-02-02 Ver
510(k) K230284 Penumbra LP Coil SystemHCG2023-10-25 Ver
510(k) K223186 Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2023-02-13 Ver
510(k) K222808 Penumbra System (Reperfusion Catheter RED 43)NRY2022-12-20 Ver
510(k) K222358 Indigo Aspiration System - Lightning FlashQEW2022-12-20 Ver
510(k) K221822 BENCHMARK BMX81 Access SystemQJP2022-11-04 Ver
510(k) K220683 INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)QEW2022-10-04 Ver
510(k) K213390 Benchmark BMX96 Access SystemQJP2022-08-18 Ver
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