The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Wallflex Enternal Colonic Stent And Anchor Lock Delivery System.
| Device ID | K042065 |
| 510k Number | K042065 |
| Device Name: | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Kathleen Morahan |
| Correspondent | Kathleen Morahan 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 | 2004-08-02 |
| Decision Date | 2004-09-30 |
| Summary: | summary |