The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Axs Offset Delivery Assist Catheter.
| Device ID | K163259 |
| 510k Number | K163259 |
| Device Name: | AXS Offset Delivery Assist Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | STRYKER NEUROVASCULAR 47900 Bayside Parkway Fremont, CA 94538 |
| Contact | Shazia Hakim |
| Correspondent | Angelica Beckmann STRYKER NEUROVASCULAR 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 | 2016-11-21 |
| Decision Date | 2017-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327361155 | K163259 | 000 |