Eclipse 2L — Balt USA, LLC (510(k) K183045)
Eclipse 2L — Balt USA, LLC (510(k) K183045) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Eclipse 2L; Applicant: Balt USA, LLC; Clearance track: 510(k).
| Device name | Eclipse 2L |
|---|---|
| Applicant | Balt USA, LLC |
| Clearance track | 510(k) |
| Submission number | K183045 |
| Decision | Substantially Equivalent |
| Decision date | 2019-04-30 |
| Date received | 2018-11-02 |
| Product code | MJN |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | CA, US |
| Source | openFDA device |
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