The following data is part of a premarket notification filed by Stryker with the FDA for Axs Catalyst Distal Access Catheter 058 X 115cm; Axs Catalyst Distal Access Catheter 058 X 132cm; Axs Catalyst Distal Access Catheter 060 X 132cm.
| Device ID | K173841 |
| 510k Number | K173841 |
| Device Name: | AXS Catalyst Distal Access Catheter 058 X 115cm; AXS Catalyst Distal Access Catheter 058 X 132cm; AXS Catalyst Distal Access Catheter 060 X 132cm |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Contact | Angelica Beckmann |
| Correspondent | Angelica Beckmann 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 | 2017-12-18 |
| Decision Date | 2018-03-18 |
| Summary: | summary |