Wirion 7-10078-01

GUDID 10850000491882

Wirion Embolic Protection System

Cardiovascular Systems, Inc.

Embolic protection filtering guidewire
Primary Device ID10850000491882
NIH Device Record Keyfe93c6bc-9932-4284-93e9-139fd395b56a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWirion
Version Model NumberWRN-D6
Catalog Number7-10078-01
Company DUNS024954518
Company NameCardiovascular Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110850000491882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTETemporary Carotid Catheter For Embolic Capture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-15
Device Publish Date2021-03-05

Devices Manufactured by Cardiovascular Systems, Inc.

10852528005169 - Diamondback Coronary2023-12-18 DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM
10852528005176 - Diamondback Coronary2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
30852528005187 - Diamondback Coronary2023-12-18 Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
10852528005336 - Diamondback Coronary2023-12-18 DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown
10852528005428 - Diamondback Coroanry2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
10852528005787 - Diamondback Coronary2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
10852528005800 - Diamondback Coronary2023-12-18 SALINE INFUSION PUMP (SIP)
10852528005442 - Diamondback Coronary2023-12-11 SALINE INFUSION PUMP (SIP)

Trademark Results [Wirion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WIRION
WIRION
90482804 not registered Live/Pending
Cardiovascular Systems, Inc.
2021-01-22
WIRION
WIRION
79122198 4344910 Live/Registered
Cardiovascular Systems, Inc.
2012-10-14

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