FDA.reportPublic FDA data

CARBOMEDICS SUPRA-ANNULAR (TOP HAT)

Primary DI
08022057012913
Brand
CARBOMEDICS SUPRA-ANNULAR (TOP HAT)
Company
CORCYM SRL
Model
S5-023
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
P900060001
P900060002
P900060003
P900060005
P900060006
P900060007
P900060009
P900060010
P900060013
P900060014
P900060020
P900060030
P900060032
P900060033
P900060034
P900060037
P900060039
P900060041
P900060049
P900060050

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900060001CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060002CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060003CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060005CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060006CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060007CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060009CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)Corcym S.r.l.1993-09-29LWQ
P900060010CARBOMEDICS 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
08022057012913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08022057012913080220570129138022057012913

GMDN Terms#

Term, Definition table
TermDefinition
Aortic bi-leaflet mechanical heart valve prosthesisAn artificial substitute for a natural aortic heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. It consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about pyrolytic carbon or metal struts attached to the valve housing by hinges; the hinge points intersect the valve lumen resulting in a total of three openings. When pressurized blood hits the valve, the two halves of the circle fold away from the valve ring and allow blood to flow into the three openings before the valve flaps close again.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415067044334Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044358Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
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