The following data is part of a premarket notification filed by Stryker with the FDA for Synchro2 Support Guidewire.
| Device ID | K190843 |
| 510k Number | K190843 |
| Device Name: | Synchro2 Support Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Contact | Lorraine Mazzeo |
| Correspondent | Lorraine Mazzeo Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327459661 | K190843 | 000 |
| 07613327459654 | K190843 | 000 |
| 07613327459647 | K190843 | 000 |
| 07613327459630 | K190843 | 000 |