The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Via Microcatheter (size 17), Via Microcatheter (size 21), Via Microcatheter (size 27), Via Microcatheter (size 33).
| Device ID | K192135 |
| 510k Number | K192135 |
| Device Name: | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) |
| Classification | Catheter, Percutaneous |
| Applicant | MicroVention, Inc. 1311 Valencia Ave. Tustin, CA 92780 |
| Contact | Sapna Singh |
| Correspondent | Sapna Singh MicroVention, Inc. 1311 Valencia Ave. 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 | 2019-08-07 |
| Decision Date | 2019-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842429106457 | K192135 | 000 |
| 00842429106440 | K192135 | 000 |
| 00842429106433 | K192135 | 000 |
| 00842429106426 | K192135 | 000 |
| 00842429106419 | K192135 | 000 |
| 00842429106402 | K192135 | 000 |