The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Ultraflex Precision Colonic Stent.
| Device ID | K030769 |
| 510k Number | K030769 |
| Device Name: | ULTRAFLEX PRECISION COLONIC STENT |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | Kathleen Morahan |
| Correspondent | Kathleen Morahan BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2003-07-14 |
| Summary: | summary |