The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Idc Interlocking Detachable Coil.
Device ID | K141378 |
510k Number | K141378 |
Device Name: | IDC INTERLOCKING DETACHABLE COIL |
Classification | Device, Vascular, For Promoting Embolization |
Applicant | Boston Scientific Corporation ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
Contact | Liz Johnston |
Correspondent | Liz Johnston Boston Scientific Corporation 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 | 2014-05-27 |
Decision Date | 2014-10-08 |
Summary: | summary |