The following data is part of a premarket notification filed by Corindus, Inc. with the FDA for Corpath Grx System.
| Device ID | K202275 |
| 510k Number | K202275 |
| Device Name: | CorPath GRX System |
| Classification | System, Catheter Control, Steerable |
| Applicant | Corindus, Inc. 309 Waverley Oaks Road, Suite 105 Waltham, MA 02452 |
| Contact | Dana Hartlein |
| Correspondent | Dana Hartlein Corindus, Inc. 309 Waverley Oaks Road, Suite 105 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 | 2020-08-11 |
| Decision Date | 2020-12-11 |