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Balt USA, LLC

19 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
SLIM Microcatheter (K260199)Balt USA, LLC2026-07-13
Next Generation 088 Catheter (K254223)Balt USA, LLC2026-04-16
Optima Coil System (OptiOne Coil System) (K254221)Balt USA, LLC2026-01-27
Carrier XL Delivery Catheter (K252569)Balt USA, LLC2025-10-22
Optima Coil System (Optima Packing Coil System) (K252700)Balt USA, LLC2025-09-26
Raptor Aspiration Catheter; Balt Aspiration Tubing Set (K243948)Balt USA, LLC2025-06-03
Prestige Coil System (Prestige Packing Line Extension) (K251383)Balt USA, LLC2025-05-30
Next Generation Access Platform (K242376)Balt USA, LLC2024-12-30
Optima Coil System (OptiBlock Line Extension) (K242582)Balt USA, LLC2024-09-27
Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (K234083)Balt USA, LLC2024-07-02
Next Generation Access Catheter (K234074)Balt USA, LLC2024-07-02
NG Delivery Catheter (K230609)Balt USA, LLC2023-09-13
Optima Coil System (K223386)Balt USA, LLC2022-12-06
MAGIC Flow-Dependent Microcatheter (K213435)Balt USA, LLC2022-07-19
MAGIC Infusion Catheter (K202366)Balt USA, LLC2021-01-29
Optima Coil System (K200030)Balt USA, LLC2020-02-01
Eclipse 2L (K183045)Balt USA, LLC2019-04-30
Ballast 088 Long Sheath (K182918)Balt USA, LLC2019-03-21
HYBRID Guidewire (K182337)Balt USA, LLC2018-10-04

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Every clearance here is in the API, with alerts when new ones post.