The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Mirage Hydrophilic Guidewire, Model 103-0608.
| Device ID | K002212 |
| 510k Number | K002212 |
| Device Name: | MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 |
| Classification | Wire, Guide, Catheter |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Maribelle Aguinaldo |
| Correspondent | Maribelle Aguinaldo 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 | 2000-07-21 |
| Decision Date | 2000-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536004795 | K002212 | 000 |
| 00763000518912 | K002212 | 000 |