The following data is part of a premarket notification filed by Micro Vention Inc. with the FDA for Sofia Ex Intracranial Support Catheter.
| Device ID | K182602 |
| 510k Number | K182602 |
| Device Name: | SOFIA EX Intracranial Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Micro Vention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Contact | Tina Ariaee |
| Correspondent | Tina Ariaee 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 | 2018-09-21 |
| Decision Date | 2019-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842429101582 | K182602 | 000 |
| 00842429101575 | K182602 | 000 |