The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Silverspeed Hydrophilic Guidewire, Models 103-0601-300 And 103-0602-300.
| Device ID | K010497 |
| 510k Number | K010497 |
| Device Name: | SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 |
| Classification | Wire, Guide, Catheter |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-21 |
| Decision Date | 2001-03-22 |