The following data is part of a premarket notification filed by Stryker with the FDA for Axs Catalyst 7 Distal Access Catheter (068 X 115cm, 068 X 125cm, 068 X 132cm).
| Device ID | K183464 |
| 510k Number | K183464 |
| Device Name: | AXS Catalyst 7 Distal Access Catheter (068 X 115cm, 068 X 125cm, 068 X 132cm) |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Contact | Germaine Fu |
| Correspondent | Germaine Fu Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-14 |
| Decision Date | 2019-03-13 |