The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Headway 27 Microcatheter.
| Device ID | K142449 |
| 510k Number | K142449 |
| Device Name: | Headway 27 Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Contact | Cynthia Valenzuela |
| Correspondent | Cynthia Valenzuela 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 | 2014-09-02 |
| Decision Date | 2015-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987350609199 | K142449 | 000 |
| 00811425021385 | K142449 | 000 |