The following data is part of a premarket notification filed by Corindus, Inc. with the FDA for Corpath Grx System.
Device ID | K173288 |
510k Number | K173288 |
Device Name: | CorPath GRX System |
Classification | System, Catheter Control, Steerable |
Applicant | Corindus, Inc. 309 Waverley Oaks Road Waltham, MA 02452 |
Contact | Robert Lavado |
Correspondent | Robert Lavado Corindus, Inc. 309 Waverley Oaks Road Waltham, MA 02452 |
Product Code | DXX |
CFR Regulation Number | 870.1290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-16 |
Decision Date | 2018-02-15 |
Summary: | summary |