SavvyWire
Wire, Guide, Catheter
Opsens Inc.
The following data is part of a premarket notification filed by Opsens Inc. with the FDA for Savvywire.
Pre-market Notification Details
| Device ID | K213854 |
| 510k Number | K213854 |
| Device Name: | SavvyWire |
| Classification | Wire, Guide, Catheter |
| Applicant | Opsens Inc. 750 Boulevard Du Parc Technologique Québec, CA G1P 4S3 |
| Contact | Marc Chaunet |
| Correspondent | Christina Henza Ultra Lifescience Solutions, Inc. 2811 Milton Ave, #409 Janesville, WI 53545 |
| Product Code | DQX |
| Subsequent Product Code | DXO |
| Subsequent Product Code | LDF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-10 |
| Decision Date | 2022-09-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540184130023 | K213854 | 000 |
| 07540184130016 | K213854 | 000 |
Trademark Results [SavvyWire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAVVYWIRE 90030655 not registered Live/Pending |
OPSENS INC. 2020-07-01 |
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