The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Sofia 6f Catheter.
| Device ID | K150366 |
| 510k Number | K150366 |
| Device Name: | SOFIA 6F Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MICROVENTION, INC. 1311 VALENCIA AVE 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 | 2015-02-12 |
| Decision Date | 2015-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812636020853 | K150366 | 000 |
| 00812636020846 | K150366 | 000 |
| 00812636020464 | K150366 | 000 |
| 00812636020457 | K150366 | 000 |
| 00812636020440 | K150366 | 000 |
| 00812636020433 | K150366 | 000 |
| 00812636020426 | K150366 | 000 |
| 00812636020419 | K150366 | 000 |