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Balt USA, LLC

FDA 510(k) & PMA Approved Dispositivos — 19 products

Total de dispositivos19
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K260199 SLIM MicrocatheterQJP2026-07-13 Ver
510(k) K254223 Next Generation 088 CatheterQJP2026-04-16 Ver
510(k) K254221 Optima Coil System (OptiOne Coil System)HCG2026-01-27 Ver
510(k) K252569 Carrier XL Delivery CatheterQJP2025-10-22 Ver
510(k) K252700 Optima Coil System (Optima Packing Coil System)HCG2025-09-26 Ver
510(k) K243948 Raptor Aspiration Catheter; Balt Aspiration Tubing SetNRY2025-06-03 Ver
510(k) K251383 Prestige Coil System (Prestige Packing Line Extension)KRD2025-05-30 Ver
510(k) K242376 Next Generation Access PlatformQJP2024-12-30 Ver
510(k) K242582 Optima Coil System (OptiBlock Line Extension)HCG2024-09-27 Ver
510(k) K234083 Next Generation Aspiration Catheter; Balt Aspiration Tubing SetNRY2024-07-02 Ver
510(k) K234074 Next Generation Access CatheterQJP2024-07-02 Ver
510(k) K230609 NG Delivery CatheterQJP2023-09-13 Ver
510(k) K223386 Optima Coil SystemHCG2022-12-06 Ver
510(k) K213435 MAGIC Flow-Dependent MicrocatheterKRA2022-07-19 Ver
510(k) K202366 MAGIC Infusion CatheterKRA2021-01-29 Ver
510(k) K200030 Optima Coil SystemHCG2020-02-01 Ver
510(k) K183045 Eclipse 2LMJN2019-04-30 Ver
510(k) K182918 Ballast 088 Long SheathDQY2019-03-21 Ver
510(k) K182337 HYBRID GuidewireMOF2018-10-04 Ver
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