K231629 is an FDA 510(k) clearance for the 091 Balloon Guide Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Eosolutions, Corp. (Pembroke Pines, US). The FDA issued a Cleared decision on October 31, 2023, 148 days after receiving the submission on June 5, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K231629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2023 |
| Decision Date | October 31, 2023 |
| Days to Decision | 148 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |