WIRION
Temporary Carotid Catheter For Embolic Capture
Cardiovascular Systems, Inc
The following data is part of a premarket notification filed by Cardiovascular Systems, Inc with the FDA for Wirion.
Pre-market Notification Details
| Device ID | K200198 |
| 510k Number | K200198 |
| Device Name: | WIRION |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | Cardiovascular Systems, Inc 1225 Old Hwy 8 NW Saint Paul, MN 55112 |
| Contact | Erika Huffman |
| Correspondent | Erika Huffman Cardiovascular Systems, Inc 1225 Old Hwy 8 NW Saint Paul, MN 55112 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-27 |
| Decision Date | 2020-03-18 |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.