The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Contour Emboli Pva And Fastracker-325 Infusion Catheter.
| Device ID | K030966 |
| 510k Number | K030966 |
| Device Name: | CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER |
| Classification | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Applicant | BOSTON SCIENTIFIC CORP. 10 GLENS FALLS TECHNICAL PARK Glens Falls, NY 12801 -3864 |
| Contact | Jodi Lynn Greenizen |
| Correspondent | Jodi Lynn Greenizen BOSTON SCIENTIFIC CORP. 10 GLENS FALLS TECHNICAL PARK Glens Falls, NY 12801 -3864 |
| Product Code | NAJ |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-27 |
| Decision Date | 2003-09-23 |
| Summary: | summary |