K191664 is an FDA 510(k) clearance for the SelectFlex 072 Neurovascular Access System. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Q'Apel Medical (Santa Monica, US). The FDA issued a Cleared decision on August 30, 2019, 70 days after receiving the submission on June 21, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K191664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2019 |
| Decision Date | August 30, 2019 |
| Days to Decision | 70 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 |