The following data is part of a premarket notification filed by Corindus Inc. with the FDA for Corpath 200 System.
| Device ID | K120834 |
| 510k Number | K120834 |
| Device Name: | CORPATH 200 SYSTEM |
| Classification | System, Catheter Control, Steerable |
| Applicant | CORINDUS INC. 5523 RESEARCH PARK DRIVE SUITE 110 Baltimore, MD 21228 |
| Contact | Mona Advani |
| Correspondent | Mona Advani CORINDUS INC. 5523 RESEARCH PARK DRIVE SUITE 110 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 | 2012-03-19 |
| Decision Date | 2012-07-19 |
| Summary: | summary |