The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Synchro Select Guidewire.
| Device ID | K202522 |
| 510k Number | K202522 |
| Device Name: | Synchro SELECT Guidewire |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | STRYKER NEUROVASCULAR 47900 Bayside Parkway Fremont, CA 94538 |
| Contact | Hailey Hinkle |
| Correspondent | Hailey Hinkle STRYKER NEUROVASCULAR 47900 Bayside Parkway Fremont, CA 94538 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-01 |
| Decision Date | 2020-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327508642 | K202522 | 000 |
| 07613327508505 | K202522 | 000 |
| 07613327508512 | K202522 | 000 |
| 07613327508529 | K202522 | 000 |
| 07613327508574 | K202522 | 000 |
| 07613327508581 | K202522 | 000 |
| 07613327508598 | K202522 | 000 |
| 07613327508604 | K202522 | 000 |
| 07613327508611 | K202522 | 000 |
| 07613327508628 | K202522 | 000 |
| 07613327508635 | K202522 | 000 |
| 07613327508499 | K202522 | 000 |