The following data is part of a premarket notification filed by Techdevice Corporation with the FDA for Techdevice Guidewire.
| Device ID | K053251 |
| 510k Number | K053251 |
| Device Name: | TECHDEVICE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | TECHDEVICE CORPORATION 650 PLEASANT ST. Watertown, MA 02472 |
| Contact | Leigh Hayward |
| Correspondent | Leigh Hayward TECHDEVICE CORPORATION 650 PLEASANT ST. Watertown, MA 02472 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-21 |
| Decision Date | 2006-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850758007086 | K053251 | 000 |
| 00850758007079 | K053251 | 000 |
| 00850758007062 | K053251 | 000 |
| 00850758007055 | K053251 | 000 |
| 00850758007048 | K053251 | 000 |
| 00850758007031 | K053251 | 000 |
| 00850758007024 | K053251 | 000 |
| 00850758007017 | K053251 | 000 |
| 00850758007000 | K053251 | 000 |