K234115 is an FDA 510(k) clearance for the APRO 55 Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Alembic, LLC (Mountain View, US). The FDA issued a Cleared decision on March 15, 2024, 79 days after receiving the submission on December 27, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K234115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2023 |
| Decision Date | March 15, 2024 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |