The following data is part of a premarket notification filed by Corindus, Inc. with the FDA for Corpath 200 System.
| Device ID | K150892 |
| 510k Number | K150892 |
| Device Name: | CorPath 200 System |
| Classification | System, Catheter Control, Steerable |
| Applicant | CORINDUS, INC. 309 Waverley Oaks Road Suite 105 Waltham, MA 02452 |
| Contact | Milind Gramopadhye |
| Correspondent | Mona Advani CardioMed Device Consultants 5523 Research Park Drive Suite 205 Baltimore, MD 21228 |
| Product Code | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-02 |
| Decision Date | 2015-10-02 |
| Summary: | summary |