Cardica C-Port xA Plus Anastomosis System

Primary DI
11814900001007
Brand
Cardica C-Port xA Plus Anastomosis System
Company
AESDEX, LLC
Model
FG-000100
Catalog number
FG-000100
Device description
C-Port xA Plus Anastomosis System
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZPClip, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101018000CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100Cardica, Inc.2010-06-25FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
11814900001007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1181490000100711814900001007

GMDN Terms#

Term, Definition table
TermDefinition
Vascular-grafting anastomosis systemAn assembly of sterile devices designed to create an opening between a blood vessel and a vascular graft (native or synthetic) during a vascular surgical procedure [e.g., coronary artery bypass grafting (CABG), or arteriovenous fistula (AVF) grafting]. It typically includes a delivery tool loaded with metallic clips/connectors/couplers (e.g., surgical stainless steel). A blood vessel graft is loaded into the delivery tool, and upon manual actuation of the tool, the fastening devices are deployed through the graft and into the target vessel, and the tool creates an opening in the target vessel (e.g., aortotomy, arteriotomy). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081132841
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
11814900000031Cardica Vein/Aorta GaugeFG-000003FG-0000032019-02-19
11814900003100MicroCutter 30 White ReloadFG-025310FG-0253102016-08-08
11814900003117MicroCutter 30 Curved Tip White ReloadFG-025311FG-0253112016-08-08
11814900003209MicroCutter 30 Blue ReloadFG-025320FG-0253202016-08-08
11814900003216MicroCutter 30 Curved Tip Blue ReloadFG-025321FG-0253212016-08-08
11814900000017Cardica PAS-Port Proximal Anastomosis SystemFG-000001FG-0000012016-08-08
11814900001502Cardica C-Port Flex-A Plus Distal Anastomosis SystemFG-000150FG-0001502016-08-08
11814900003025Dextera MicroCutter 5/80 StaplerFG-025302FG-0253022016-07-25

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