The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Transend 300 Es Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815.
| Device ID | K022357 |
| 510k Number | K022357 |
| Device Name: | TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 |
| Classification | Wire, Guide, Catheter |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | George J Prendergast |
| Correspondent | George J Prendergast BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-19 |
| Decision Date | 2002-10-16 |
| Summary: | summary |