The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Wallflex Colonic Soft Stent System With Anchor Lock Delivery System, Wallflex Duodenal Soft Stent System With Anchor Lock Delivery System.
| Device ID | K200257 |
| 510k Number | K200257 |
| Device Name: | WallFlex Colonic Soft Stent System With Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System With Anchor Lock Delivery System |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Catherine Sanford |
| Correspondent | Catherine Sanford Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08714729902607 | K200257 | 000 |
| 08714729902591 | K200257 | 000 |
| 08714729902584 | K200257 | 000 |
| 08714729902515 | K200257 | 000 |
| 08714729902508 | K200257 | 000 |
| 08714729902492 | K200257 | 000 |