The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Flowrider Flow Directed Micro Catheter, Model 105-5065.
| Device ID | K010004 |
| 510k Number | K010004 |
| Device Name: | FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 |
| Classification | Catheter, Continuous Flush |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Eben Gorden |
| Correspondent | Eben Gorden 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 | 2001-01-02 |
| Decision Date | 2001-02-13 |