ProCatid System kit Finished Good

Primary DI
07290015512015
Brand
ProCatid System kit Finished Good
Company
GARDIA MEDICAL LTD
Model
P2-9-0705-S
Catalog number
P2-9-0705-S
Device description
"The ProCatid Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014"" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire.SYSTEM COMPONENTS:1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039 "
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
72900155120103PreviousGS10
07290015512015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7290015512010372900155120103
07290015512015072900155120157290015512015

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
+97246277166eitan@allium-medical.com
+97246277166info@allium-medical.com

Regulatory Flags#

DUNS number
531908965
Device count
1
Kit
true
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
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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