K240746 is an FDA 510(k) clearance for the Neurovascular Access System Family. This device is classified as a Catheter, Percutaneous, Neurovasculature (Class II - Special Controls, product code QJP).
Submitted by Q'Apel Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on November 20, 2024, 246 days after receiving the submission on March 19, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250. To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures.
| 510(k) Number | K240746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2024 |
| Decision Date | November 20, 2024 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QJP - Catheter, Percutaneous, Neurovasculature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures |