K183045 is an FDA 510(k) clearance for the Eclipse 2L. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on April 30, 2019, 179 days after receiving the submission on November 2, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K183045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2018 |
| Decision Date | April 30, 2019 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MJN - Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |