The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Headway 21 Microcatheter, Model: Mc212150s.
| Device ID | K093160 |
| 510k Number | K093160 |
| Device Name: | HEADWAY 21 MICROCATHETER, MODEL: MC212150S |
| 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 | 2009-10-06 |
| Decision Date | 2009-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812636020945 | K093160 | 000 |
| 00810170014857 | K093160 | 000 |