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FDA 510(k) Applications Submitted by Balt USA, LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230609
03/06/2023
NG Delivery Catheter
Balt USA, LLC
K202366
08/19/2020
MAGIC Infusion Catheter
Balt USA, LLC
K223386
11/07/2022
Optima Coil System
Balt USA, LLC
K200030
01/07/2020
Optima Coil System
Balt USA, LLC
K182337
08/28/2018
HYBRID Guidewire
Balt USA, LLC
K183045
11/02/2018
Eclipse 2L
Balt USA, LLC
K213435
10/22/2021
MAGIC Flow-Dependent Microcatheter
Balt USA, LLC
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