The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Traxcess 14ex Guidewire And Traxcess Docking Wire.
| Device ID | K093397 |
| 510k Number | K093397 |
| Device Name: | TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-30 |
| Decision Date | 2009-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170014864 | K093397 | 000 |