The following data is part of a premarket notification filed by Bostonscientific with the FDA for Interlock Fibered Idc Occlusion System.
| Device ID | K102912 |
| 510k Number | K102912 |
| Device Name: | INTERLOCK FIBERED IDC OCCLUSION SYSTEM |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | BOSTONSCIENTIFIC ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Debbie Mcintire |
| Correspondent | Debbie Mcintire BOSTONSCIENTIFIC ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-01 |
| Decision Date | 2011-03-03 |
| Summary: | summary |