The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Contour Polaris Ureteral Stent.
| Device ID | K010002 |
| 510k Number | K010002 |
| Device Name: | CONTOUR POLARIS URETERAL STENT |
| Classification | Stent, Ureteral |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Linda J Varroso |
| Correspondent | Linda J Varroso BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-02 |
| Decision Date | 2001-01-22 |