Wirion Delivery Catheter P2-9-0701

GUDID 72900155120202

The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Delivery Catheter: Contains and delivers a Filter Unit, locks it onto the guide wire using the Activating Handle and deploys it in the target vessel (Fig. 1). The Filter Unit is made of a filter membrane and a Nitinol frame. A 5cc syringe with a soft needle is supplied for flushing the system prior to use.

GARDIA MEDICAL LTD

Embolic protection filtering guidewire
Primary Device ID72900155120202
NIH Device Record Key715d1263-f201-443d-9338-57e4e116b12a
Commercial Distribution Discontinuation2018-07-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameWirion Delivery Catheter
Version Model NumberP2-9-0701
Catalog NumberP2-9-0701
Company DUNS531908965
Company NameGARDIA MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97246277166
Emailinfo@allium-medical.com
Phone+97246277166
Emailinfo@allium-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS172900155120202 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-09
Device Publish Date2016-08-11

On-Brand Devices [Wirion Delivery Catheter]

07290015512022The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Deli
72900155120202The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Del

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