FDA 510(k) Applications Submitted by Balt USA, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K242376 |
08/09/2024 |
Next Generation Access Platform |
Balt USA, LLC |
| K234083 |
12/22/2023 |
Next Generation Aspiration Catheter; Balt Aspiration Tubing Set |
Balt USA, LLC |
| K230609 |
03/06/2023 |
NG Delivery Catheter |
Balt USA, LLC |
| K234074 |
12/22/2023 |
Next Generation Access Catheter |
Balt USA, LLC |
| K243948 |
12/23/2024 |
Raptor Aspiration Catheter; Balt Aspiration Tubing Set |
Balt USA, LLC |
| K202366 |
08/19/2020 |
MAGIC Infusion Catheter |
Balt USA, LLC |
| K251383 |
05/02/2025 |
Prestige Coil System (Prestige Packing Line Extension) |
Balt USA, LLC |
| K242582 |
08/30/2024 |
Optima Coil System (OptiBlock Line Extension) |
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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