FDA.reportPublic FDA data

Wirion Delivery Catheter

Primary DI
72900155120202
Brand
Wirion Delivery Catheter
Company
GARDIA MEDICAL LTD
Model
P2-9-0701
Catalog number
P2-9-0701
Device description
The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105Delivery 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.
Published
2016-08-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTETemporary Carotid Catheter For Embolic Capture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTETemporary Carotid Catheter For Embolic CaptureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143570000WIRIONGardia Medical2015-06-04NTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
72900155120202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7290015512020272900155120202

GMDN Terms#

Term, Definition table
TermDefinition
Embolic protection filtering guidewireA steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246277166info@allium-medical.com

Regulatory Flags#

DUNS number
531908965
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015512039ProCatid Retrieval CatheterP4-9-0703P4-9-07032017-02-12
07290015512015ProCatid System kit Finished GoodP2-9-0705-SP2-9-0705-S2017-02-12
07290015512022ProCatid Delivery CatheterP2-9-0701P2-9-07012017-02-12
72900155120103Wirion System kit Finished GoodP2-9-0705-SP2-9-0705-S2016-08-11
72900155120301Wirion Retrieval CatheterP4-9-0703P4-9-07032016-08-11

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