FDA.reportPublic FDA data

PERCEVAL PLUS

Primary DI
08022057015396
Brand
PERCEVAL PLUS
Company
CORCYM SRL
Model
PVF-XL
Catalog number
PVF-XL
Device description
SUTURELESS AORTIC HEART VALVE
Published
2025-05-07
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
LWRHeart-Valve, Non-Allograft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWRHeart-Valve, Non-Allograft TissueUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150011013
P150011028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150011013PERCEVAL SUTURELESS HEART VALVECorcym S.r.l.2016-01-08LWR
P150011028PERCEVAL SUTURELESS HEART VALVECorcym S.r.l.2016-01-08LWR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08022057015396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08022057015396080220570153968022057015396

GMDN Terms#

Term, Definition table
TermDefinition
Aortic heart valve bioprosthesisA xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
441454802
Device count
1
Lot or batch
true
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
00690103220223TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
08022057014696PERCEVALCORCYM SRLLWR2025-05-09
08022057014702PERCEVALCORCYM SRLLWR2025-05-09
08022057014719PERCEVALCORCYM SRLLWR2025-05-09
08022057014726PERCEVALCORCYM SRLLWR2025-05-09
08022057015365PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015372PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015389PERCEVAL PLUSCORCYM SRLLWR2025-05-07
00763000926489Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926496Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926502Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926519Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926526Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000647025Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647032Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647049Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647056Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647063Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647070Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
05415067045447Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045454Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045461Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045478Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
08022057015532Perceval RELYON PAK CORCYM SRLLWR2022-11-11
08022057015549Perceval RELYON PAK CORCYM SRLLWR2022-11-11
08022057015556Perceval RELYON PAK CORCYM SRLLWR2022-11-11