The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow Hpc Flow Directed Micro Catheter, Reba.
| Device ID | K093750 |
| 510k Number | K093750 |
| Device Name: | ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA |
| Classification | Catheter, Continuous Flush |
| Applicant | EV3 INC 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Laura Heaton |
| Correspondent | Laura Heaton EV3 INC 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-07 |
| Decision Date | 2009-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536026896 | K093750 | 000 |
| 00836462002371 | K093750 | 000 |
| 00836462002364 | K093750 | 000 |
| 00836462002357 | K093750 | 000 |
| 00836462002340 | K093750 | 000 |
| 00836462002272 | K093750 | 000 |
| 00836462002258 | K093750 | 000 |
| 00836462002241 | K093750 | 000 |
| 00836462002234 | K093750 | 000 |
| 00836462002227 | K093750 | 000 |
| 00836462002210 | K093750 | 000 |
| 00836462002197 | K093750 | 000 |
| 00836462002180 | K093750 | 000 |
| 00836462002142 | K093750 | 000 |
| 00836462002081 | K093750 | 000 |
| 00836462002043 | K093750 | 000 |
| 00836462002036 | K093750 | 000 |
| 00836462002456 | K093750 | 000 |
| 00836462002135 | K093750 | 000 |
| 00847536026872 | K093750 | 000 |
| 00847536026858 | K093750 | 000 |
| 00847536026834 | K093750 | 000 |
| 00847536026810 | K093750 | 000 |
| 00847536026773 | K093750 | 000 |
| 00847536026735 | K093750 | 000 |
| 00847536006317 | K093750 | 000 |
| 00847536006294 | K093750 | 000 |
| 00847536006270 | K093750 | 000 |
| 00847536006256 | K093750 | 000 |
| 00847536005983 | K093750 | 000 |
| 00847536005969 | K093750 | 000 |
| 00847536005952 | K093750 | 000 |
| 00847536005938 | K093750 | 000 |
| 00847536005914 | K093750 | 000 |
| 00847536005891 | K093750 | 000 |
| 00763000412487 | K093750 | 000 |