K183463 is an FDA 510(k) clearance for the AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Stryker (Fremont, US). The FDA issued a Cleared decision on March 13, 2019, 89 days after receiving the submission on December 14, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K183463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2018 |
| Decision Date | March 13, 2019 |
| Days to Decision | 89 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 |