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
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
05415067052742Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052759Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052766Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052780Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052797Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052803Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052810Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052827Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052834Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052858Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052865Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052872Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052889Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052896Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052902Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
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