The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Wedge Microcatheter.
| Device ID | K172014 |
| 510k Number | K172014 |
| Device Name: | Wedge Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Micro Vention, Inc. 1311 Valencia Avenue Tustin, CA 92780 |
| Contact | Chet Jones |
| Correspondent | Marina Emond Micro Vention, Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816777025838 | K172014 | 000 |