FDA.reportPublic FDA data

CARBOMEDICS CARBO-SEAL

Primary DI
08022057013477
Brand
CARBOMEDICS CARBO-SEAL
Company
CORCYM SRL
Model
AP-023
Published
2014-07-23
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
LWQHEART-VALVE, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWQHeart-Valve, MechanicalUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P900060012
P900060013
P900060014
P900060020
P900060030
P900060032
P900060033
P900060034
P900060037
P900060039
P900060041
P900060049
P900060050

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900060012CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060013CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060014CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060020CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060030CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060032CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060033CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060034CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060037CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060039CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060041CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060049CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060050CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08022057013477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08022057013477080220570134778022057013477

GMDN Terms#

Term, Definition table
TermDefinition
Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graftAn artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). The valve component consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about struts attached to the valve housing by hinges; the synthetic polymer blood vessel is designed to conform to the aortic root anatomy and is impregnated with a bioabsorbable animal-derived gelatin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
441454802
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08022057015747JOSEPH LAMELAS Atrial Lift SystemMI-ALS-001MI-ALS-0012026-02-03
08022057015754CUFF Aortic Root Exposure DeviceMI-CUFF-001MI-CUFF-0012026-02-03
08022057015853SUTURE BELT Circumferential Suture OrganizerMI-ISBA-001MI-ISBA-0012026-02-03
08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureMI-COTIE-001MI-COTIE-0012026-02-03
08022057015877JOSEPH LAMELAS Knot PusherMI-KP-001MI-KP-0012026-02-03
08022057015884DeTACH Aortic Cross Clamp Head-LargeMI-XCHL-851MI-XCHL-8512026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallMI-XCHS-551MI-XCHS-5512026-02-03
18022057015744JOSEPH LAMELAS Atrial Lift SystemMI-ALS-001MI-ALS-0012026-02-03
18022057015751CUFF Aortic Root Exposure DeviceMI-CUFF-001MI-CUFF-0012026-02-03
08022057015761JOSEPH LAMELAS Intercostal Retractor System KitMI-IRS-222MI-IRS-2222026-02-03
08022057015778JOSEPH LAMELAS Intercostal Retractor System Retractor RackMI-IRS-R-001MI-IRS-R-0012026-02-03
08022057015785JOSEPH LAMELAS Intercostal Retractor System Small Blade SetMI-IRS-SB-P01MI-IRS-SB-P012026-02-03
08022057015792JOSEPH LAMELAS Intercostal Retractor System Medium Blade SetMI-IRS-MB-P01MI-IRS-MB-P012026-02-03
08022057015808JOSEPH LAMELAS Intercostal Retractor System Large Blade SetMI-IRS-LB-P01MI-IRS-LB-P012026-02-03
08022057015815JOSEPH LAMELAS Intercostal Retractor System Extra Large Blade SetMI-IRS-XLB-P01MI-IRS-XLB-P012026-02-03
08022057015822JOSEPH LAMELAS Intercostal Retractor System Small Double Swivel Blade SetMI-IRS-SDSB-22MI-IRS-SDSB-222026-02-03
08022057015839JOSEPH LAMELAS Intercostal Retractor System Medium Double Swivel Blade SetMI-IRS-MDSB-22MI-IRS-MDSB-222026-02-03
08022057015846JOSEPH LAMELAS Intercostal Retractor System Sterilization TrayMI-IRS-T-22MI-IRS-T-222026-02-03
18022057015850SUTURE BELT Circumferential Suture OrganizerMI-ISBA-001MI-ISBA-0012026-02-03
18022057015867TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureMI-COTIE-001MI-COTIE-0012026-02-03

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Primary DI, Brand, Company table
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