The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Interceptor Plus Coronary Filter Systems.
Device ID | K073523 |
510k Number | K073523 |
Device Name: | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS |
Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
Applicant | MEDTRONIC INC. 37A CHERRY HILL DRIVE Danvers, MA 01923 |
Contact | Colleen Mullins |
Correspondent | Colleen Mullins MEDTRONIC INC. 37A CHERRY HILL DRIVE Danvers, MA 01923 |
Product Code | NFA |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-14 |
Decision Date | 2008-08-01 |
Summary: | summary |