The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Echelon Micro Catheter, Model 105-5091.
| Device ID | K031992 |
| 510k Number | K031992 |
| Device Name: | ECHELON MICRO CATHETER, MODEL 105-5091 |
| Classification | Catheter, Continuous Flush |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Marilyn R Pourazar |
| Correspondent | Marilyn R Pourazar MICRO THERAPEUTICS, INC. 2 GOODYEAR 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 | 2003-06-27 |
| Decision Date | 2003-08-07 |
| Summary: | summary |