The following data is part of a premarket notification filed by Medtronic Advanced Energy with the FDA for Corecath 2.7s.
Device ID | K170296 |
510k Number | K170296 |
Device Name: | CoreCath 2.7S |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801 |
Contact | Lydia Sakakeeny |
Correspondent | Lydia Sakakeeny Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-31 |
Decision Date | 2017-03-20 |
Summary: | summary |