The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Wallflex Enteral Colonic Stent With Anchor Lock Delivery System.
| Device ID | K061877 |
| 510k Number | K061877 |
| Device Name: | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Elena Bickoff |
| Correspondent | Elena Bickoff BOSTON SCIENTIFIC CORP. 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 | 2006-07-03 |
| Decision Date | 2006-09-15 |
| Summary: | summary |