The following data is part of a premarket notification filed by Techdevice Corporation with the FDA for Endologix Guidewire.
| Device ID | K110241 |
| 510k Number | K110241 |
| Device Name: | ENDOLOGIX GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | TECHDEVICE CORPORATION 650 PLEASANT ST. Watertown, MA 02472 |
| Contact | Gary Bunnewith |
| Correspondent | Gary Bunnewith TECHDEVICE CORPORATION 650 PLEASANT ST. Watertown, MA 02472 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-27 |
| Decision Date | 2011-02-25 |
| Summary: | summary |