The following data is part of a premarket notification filed by Stryker with the FDA for Axs Catalyst Distal Access Catheter 058x115cm, Axs Catalyst Distal Access Catheter 058x132cm, Axs Catalyst Distal Access Catheter 060x132cm.
| Device ID | K151667 |
| 510k Number | K151667 |
| Device Name: | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm |
| Classification | Catheter, Percutaneous |
| Applicant | Stryker 47900 BAYSIDE PARKWAY Fremont, CA 94538 |
| Contact | Rhoda M Santos |
| Correspondent | Rhoda M Santos 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 | 2015-06-19 |
| Decision Date | 2015-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327012033 | K151667 | 000 |
| 07613327012019 | K151667 | 000 |
| 07613327011999 | K151667 | 000 |