The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Sofia Distal Access Catheter.
| Device ID | K131482 |
| 510k Number | K131482 |
| Device Name: | SOFIA DISTAL ACCESS CATHETER |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-23 |
| Decision Date | 2013-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987350999795 | K131482 | 000 |
| 00816777025913 | K131482 | 000 |
| 00810170019623 | K131482 | 000 |
| 00810170019234 | K131482 | 000 |