FDA.reportPublic FDA data

MITROFLOW

Primary DI
00896208000108
Brand
MITROFLOW
Company
Corcym Canada Corp
Model
LXA21
Published
2014-09-19
Public version status
Update
Distribution status
Not 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
P060038002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060038002MITROFLOW AORTIC PERICARDIAL HEART VALVECorcym Canada Corp2007-10-23LWR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896208000108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896208000108008962080001088962080001080896208000108

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
204322622
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00896208000795PERCEVAL PLUSPVF-S2021-01-26
00896208000801PERCEVAL PLUSPVF-M2021-01-26
00896208000818PERCEVAL PLUSPVF-L2021-01-26
00896208000825PERCEVAL PLUSPVF-XL2021-01-26
00896208000528CROWN PRTCNA232016-08-08
00896208000535CROWN PRTCNA252016-08-08
00896208000542CROWN PRTCNA272016-08-08
00896208000412PERCEVALPVS21PVS212016-02-25
00896208000429PERCEVALPVS23PVS232016-02-25
00896208000436PERCEVALPVS25PVS252016-02-25
00896208000443PERCEVALPVS27PVS272016-02-25
08022057014924MITROFLOW VALSALVA CONDUITMVC262014-09-22
08022057014931MITROFLOW VALSALVA CONDUITMVC282014-09-22
00896208000115MITROFLOWLXA232014-09-19
00896208000122MITROFLOWLXA252014-09-19
00896208000139MITROFLOWLXA272014-09-19
00896208000153MITROFLOWDLA192014-09-19
00896208000160MITROFLOWDLA212014-09-19
00896208000177MITROFLOWDLA232014-09-19
00896208000184MITROFLOWDLA252014-09-19

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
08022057015396PERCEVAL 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