The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Wallstent Enternal Prosthesis.
| Device ID | K000281 |
| 510k Number | K000281 |
| Device Name: | WALLSTENT ENTERNAL PROSTHESIS |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Lisa M Quaglia |
| Correspondent | Lisa M Quaglia BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-05-12 |