FDA.reportPublic FDA data

Hancock™ 150

Primary DI
00763000926496
Brand
Hancock™ 150
Company
MEDTRONIC, INC.
Model
HC150-18
Device description
HANCOCK VALVED CONDUIT MO 18MM
Published
2024-07-22
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
P790007066

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P790007066HANCOCK MODIFIED ORIFICE BIOPROSTHESISMedtronic Heart Valves1979-11-15LWR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000926496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000926496007630009264967630009264960763000926496

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
00643169705753MyCareLink™24950JLQ2016-05-28
00763000354466Symplicity Spyral™RDN0162023-11-30
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02

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
00763000926502Hancock™ 150MEDTRONIC, INC.LWR2024-07-22