WIRION
Temporary Carotid Catheter For Embolic Capture
Gardia Medical Ltd.
The following data is part of a premarket notification filed by Gardia Medical Ltd. with the FDA for Wirion.
Pre-market Notification Details
| Device ID | K180023 |
| 510k Number | K180023 |
| Device Name: | WIRION |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | Gardia Medical Ltd. HaEshel 2 Caesarea, IL 3088900 |
| Contact | Vardit Segal |
| Correspondent | Vardit Segal Gardia Medical Ltd. HaEshel 2 Caesarea, IL 3088900 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-03 |
| Decision Date | 2018-03-21 |
| Summary: | summary |
Trademark Results [WIRION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WIRION 90482804 not registered Live/Pending |
Cardiovascular Systems, Inc. 2021-01-22 |
 WIRION 79122198 4344910 Live/Registered |
Cardiovascular Systems, Inc. 2012-10-14 |
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