The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Traxcess 0.014 Hydrophilic Guidewire.
| Device ID | K080863 |
| 510k Number | K080863 |
| Device Name: | TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408 |
| Contact | Kevin E Daly |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-03-28 |
| Decision Date | 2008-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811425021330 | K080863 | 000 |
| 00811425020340 | K080863 | 000 |
| 00810170012280 | K080863 | 000 |
| 00812636020006 | K080863 | 000 |