The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Headway 27 Microcatheter.
| Device ID | K110813 |
| 510k Number | K110813 |
| Device Name: | HEADWAY 27 MICROCATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-24 |
| Decision Date | 2011-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811425020449 | K110813 | 000 |
| 00810170016165 | K110813 | 000 |