FDA.reportPublic FDA data

HANCOCK® II

Primary DI
00643169534063
Brand
HANCOCK® II
Company
MEDTRONIC, INC.
Model
T505C227
Device description
VLV T505C227 HKII AOR CII NNA US TEMP
Published
2014-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYEreplacement Heart-valve
LWRheart-valve, non-allograft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYEReplacement Heart-ValveCardiovascular3
LWRHeart-Valve, Non-Allograft TissueUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980043028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980043028HANCOCK II PORCINE BIOPROSTHESISMedtronic, Inc.1999-09-28DYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169534063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169534063006431695340636431695340630643169534063

GMDN Terms#

Term, Definition table
TermDefinition
Aortic heart valve bioprosthesisA sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

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Primary DI, Brand, Company table
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00690103220247TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
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00763000990565Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
00763000990572Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
00763000990589Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
00763000990596Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
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
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00763000926472Hancock™ 150MEDTRONIC, INC.DYE2024-07-22
00763000926489Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926496Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926502Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926519Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
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00763000647049Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647056Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647063Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04