The following data is part of a premarket notification filed by Corindus, Inc. with the FDA for Corpath Grx System.
| Device ID | K160121 |
| 510k Number | K160121 |
| Device Name: | CorPath GRX System |
| Classification | System, Catheter Control, Steerable |
| Applicant | Corindus, Inc. 309 Waverley Oaks Road, Suite 105 Waltham, MA 02454 |
| Contact | Michael Douglas |
| Correspondent | Mona Advani Cardiomed Device Consultants, LLC 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 | 2016-01-19 |
| Decision Date | 2016-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816280023116 | K160121 | 000 |
| 00816280023093 | K160121 | 000 |
| 00816280023079 | K160121 | 000 |
| 00816280023055 | K160121 | 000 |
| 00816280023024 | K160121 | 000 |
| 00816280023017 | K160121 | 000 |