FDA.reportPublic FDA data

CARBOMEDICS STANDARD

Primary DI
08022057012692
Brand
CARBOMEDICS STANDARD
Company
CORCYM SRL
Model
M7-021
Catalog number
M7-021
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
P900060011
P900060013
P900060014
P900060020
P900060030
P900060032
P900060033
P900060034
P900060037
P900060039
P900060041
P900060049
P900060050

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900060011CARBOMEDICS 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
08022057012692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08022057012692080220570126928022057012692

GMDN Terms#

Term, Definition table
TermDefinition
Mitral bi-leaflet mechanical heart valve prosthesisAn artificial substitute for a natural mitral 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
08022057015952Memo 4D Curve4DC244DC242026-07-04
08022057015969Memo 4D Curve4DC264DC262026-07-04
08022057015976Memo 4D Curve4DC284DC282026-07-04
08022057015983Memo 4D Curve4DC304DC302026-07-04
08022057015990Memo 4D Curve4DC324DC322026-07-04
08022057016003Memo 4D Curve4DC344DC342026-07-04
08022057016010Memo 4D Curve4DC364DC362026-07-04
08022057016027Memo 4D Curve4DC384DC382026-07-04
08022057016034Memo 4D Curve4DC404DC402026-07-04
08022057016041Memo 4D Curve4DC424DC422026-07-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415067043078Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
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05415067043115Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043191Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043214Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043238Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043351Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043399Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043412Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043436Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043474Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043498Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043511Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043535Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043559Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043573Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043597Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043634Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043771Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043856Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043870Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044174Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044211Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044273Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044297Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044334Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044358Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044952Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067045010Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10