FDA.reportPublic FDA data

ProCatid Retrieval Catheter

Primary DI
07290015512039
Brand
ProCatid Retrieval Catheter
Company
GARDIA MEDICAL LTD
Model
P4-9-0703
Catalog number
P4-9-0703
Device description
The Retrieval Catheter is supplied as part of the ProCatid System Kit, DI 7290015512015Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.
Published
2017-02-12
Public version status
Update
Distribution status
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
72900155120301PreviousGS10
07290015512039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7290015512030172900155120301
07290015512039072900155120397290015512039

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.

Contacts#

Phone, Email table
PhoneEmail
+97246277166info@allium-medical.com
+97246277166eitan@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
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
72900155120202Wirion Delivery CatheterP2-9-0701P2-9-07012016-08-11
72900155120301Wirion Retrieval CatheterP4-9-0703P4-9-07032016-08-11

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