FDA.reportPublic FDA data

HANCOCK®

Primary DI
00613994796035
Brand
HANCOCK®
Company
MEDTRONIC, INC.
Model
H174A16
Device description
CONDUIT H174A16 LV CONNECTOR 12L
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYEreplacement Heart-valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYEReplacement Heart-ValveCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P870078008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P870078008HANCOCK PORCINE BIOPROSTHESISMedtronic, Inc.1989-09-28DYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994796035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994796035006139947960356139947960350613994796035

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftA sterile artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Heat

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000990558Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
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
00763000926465Hancock™ 150MEDTRONIC, INC.DYE2024-07-22
00763000926472Hancock™ 150MEDTRONIC, INC.DYE2024-07-22
00643169983229Avalus™MEDTRONIC, INC.DYE2024-03-09
00690103194074CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTICEdwards Lifesciences LLCDYE2019-11-27
00690103194081CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTICEdwards Lifesciences LLCDYE2019-11-27
00690103194098CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLCDYE2019-11-27
00690103194104CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLCDYE2019-11-27
00690103194128CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLCDYE2019-08-09
00690103194012CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194029CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194036CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194043CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194050CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194067CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00643169646483Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646490Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646506Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646513Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646520Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646537Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646544Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646551Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646568Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169594241HANCOCK® IIMEDTRONIC, INC.DYE2015-10-08
00643169594258HANCOCK® IIMEDTRONIC, INC.DYE2015-10-07