The following data is part of a premarket notification filed by Stryker with the FDA for Axs Catalyst Distal Access Catheter 068 X 115cm, Axs Catalyst Distal Access Catheter 068 X 125cm, Axs Catalyst Distal Access Catheter 068 X 132cm.
| Device ID | K183463 |
| 510k Number | K183463 |
| Device Name: | AXS Catalyst Distal Access Catheter 068 X 115cm, AXS Catalyst Distal Access Catheter 068 X 125cm, AXS Catalyst Distal Access Catheter 068 X 132cm |
| Classification | Catheter, Percutaneous |
| Applicant | Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Contact | Germaine Fu |
| Correspondent | Germaine Fu Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Product Code | DQY |
| 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 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327417227 | K183463 | 000 |
| 07613327417210 | K183463 | 000 |
| 07613327417203 | K183463 | 000 |