FDA.reportPublic FDA data

Hancock™

Primary DI
00763000517816
Brand
Hancock™
Company
MEDTRONIC, INC.
Model
HC150-18
Device description
CONDUIT HC150-18 HK1 MO 26L
Published
2021-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

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
P790007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P790007000HANCOCK MODIFIED ORIFICE BIOPROSTHESISMedtronic Heart Valves1979-11-15LWR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000517816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000517816007630005178167630005178160763000517816

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary open-surgery heart valve bioprosthesisA xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair/replace a dysfunctional pulmonary heart valve, or to replace a pulmonary valve in patients undergoing a pulmonary autograft (Ross) procedure. 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
Special Storage Condition, Specify00Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
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
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04
00824846003687NABB4K20R42026-07-04
00824846003700NABB4645R212026-07-04
00824846001669NABB12T12R42026-06-28
00824846001843NA9S63R22026-06-28
00824846001850NA11U35R32026-06-28
00824846001614NABB12V43R32026-06-25
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

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
08022057015396PERCEVAL PLUSCORCYM SRLLWR2025-05-07
00763000926489Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926496Hancock™ 150MEDTRONIC, INC.LWR2024-07-22