The following data is part of a premarket notification filed by Corindus, Inc. with the FDA for Corpath Grx System.
Device ID | K180517 |
510k Number | K180517 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-27 |
Decision Date | 2018-03-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816280023123 | K180517 | 000 |