The following data is part of a premarket notification filed by Micro Therapeutics, Inc D/b/a: Ev3 Inc with the FDA for Silverspeed Hydrophilic Guidewire, X-celerator Hydrophilic Exchange Guidewire, X-pedion Hydrophilic Guidewire, Mirage Hy.
| Device ID | K124007 |
| 510k Number | K124007 |
| Device Name: | SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY |
| Classification | Wire, Guide, Catheter |
| Applicant | MICRO THERAPEUTICS, INC D/B/A: EV3 INC 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Analia Staubly |
| Correspondent | Analia Staubly MICRO THERAPEUTICS, INC D/B/A: EV3 INC 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536006362 | K124007 | 000 |
| 00847536004542 | K124007 | 000 |
| 00847536004528 | K124007 | 000 |
| 00847536004504 | K124007 | 000 |
| 00847536004481 | K124007 | 000 |
| 00847536004474 | K124007 | 000 |
| 00847536004467 | K124007 | 000 |
| 00847536004443 | K124007 | 000 |
| 00847536004436 | K124007 | 000 |
| 00847536004429 | K124007 | 000 |
| 00847536004412 | K124007 | 000 |
| 00847536004399 | K124007 | 000 |
| 00847536004566 | K124007 | 000 |
| 00847536004597 | K124007 | 000 |
| 00847536004603 | K124007 | 000 |
| 00847536006348 | K124007 | 000 |
| 00847536004801 | K124007 | 000 |
| 00847536004788 | K124007 | 000 |
| 00847536004733 | K124007 | 000 |
| 00847536004719 | K124007 | 000 |
| 00847536004696 | K124007 | 000 |
| 00847536004672 | K124007 | 000 |
| 00847536004658 | K124007 | 000 |
| 00847536004641 | K124007 | 000 |
| 00847536004634 | K124007 | 000 |
| 00847536004610 | K124007 | 000 |
| 00847536004375 | K124007 | 000 |