The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Jagwire High Performance Guidwire.
| Device ID | K141820 |
| 510k Number | K141820 |
| Device Name: | JAGWIRE HIGH PERFORMANCE GUIDWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Allison Baillie |
| Correspondent | Allison Baillie BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-10-21 |
| Summary: | summary |