K192525 is an FDA 510(k) clearance for the 087 Balloon Guide Catheter System. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Q'Apel Medical, LLC (Santa Monica, US). The FDA issued a Cleared decision on October 31, 2019, 48 days after receiving the submission on September 13, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K192525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2019 |
| Decision Date | October 31, 2019 |
| Days to Decision | 48 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 |