The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Marksman Catheter, *refers To Different Catheter Working Lenghts, Distal Single Coiled Lengths And Distal Shaft Lengths.
| Device ID | K111490 |
| 510k Number | K111490 |
| Device Name: | MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS |
| Classification | Catheter, Continuous Flush |
| Applicant | EV3 INC 173 JEFFERSON DR Menlo Park, CA 94025 |
| Contact | Daniel Cher, Md |
| Correspondent | Daniel Cher, Md EV3 INC 173 JEFFERSON DR Menlo Park, CA 94025 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-31 |
| Decision Date | 2011-09-16 |
| Summary: | summary |