Wirion 7-10078-01
GUDID 10850000491882
Wirion Embolic Protection System
Cardiovascular Systems, Inc.
Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire| Primary Device ID | 10850000491882 |
| NIH Device Record Key | fe93c6bc-9932-4284-93e9-139fd395b56a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wirion |
| Version Model Number | WRN-D6 |
| Catalog Number | 7-10078-01 |
| Company DUNS | 024954518 |
| Company Name | Cardiovascular Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com |
Device Dimensions
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10850000491882 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210282
FDA Product Code
| NTE | Temporary Carotid Catheter For Embolic Capture |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-15 |
| Device Publish Date | 2021-03-05 |
Devices Manufactured by Cardiovascular Systems, Inc.
| 10852528005169 - Diamondback Coronary | 2023-12-18 DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM |
| 10852528005176 - Diamondback Coronary | 2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM |
| 30852528005187 - Diamondback Coronary | 2023-12-18 Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm |
| 10852528005336 - Diamondback Coronary | 2023-12-18 DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown |
| 10852528005428 - Diamondback Coroanry | 2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM |
| 10852528005787 - Diamondback Coronary | 2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM |
| 10852528005800 - Diamondback Coronary | 2023-12-18 SALINE INFUSION PUMP (SIP) |
| 10852528005442 - Diamondback Coronary | 2023-12-11 SALINE INFUSION PUMP (SIP) |
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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