The following data is part of a premarket notification filed by Opsens with the FDA for Optowire Deux.
| Device ID | K152991 |
| 510k Number | K152991 |
| Device Name: | OptoWire Deux |
| Classification | Wire, Guide, Catheter |
| Applicant | OPSENS 2014, CYRILLE DUQUET STREET, #125 Quebec, CA G1n 4n6 |
| Contact | Vanessa Mootoosamy |
| Correspondent | Vanessa Mootoosamy OPSENS 2014, CYRILLE DUQUET STREET, #125 Quebec, CA G1n 4n6 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-13 |
| Decision Date | 2016-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754018410121 | K152991 | 000 |
| 07540184110124 | K152991 | 000 |