The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Headway Duo Microcatheter.
| Device ID | K120917 |
| 510k Number | K120917 |
| Device Name: | HEADWAY DUO MICROCATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-27 |
| Decision Date | 2012-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170014413 | K120917 | 000 |
| 00810170014345 | K120917 | 000 |