FDA.reportPublic FDA data

Hancock™

Primary DI
00643169646544
Brand
Hancock™
Company
MEDTRONIC, INC.
Model
HC105-26
Device description
CONDUIT HC105-26 HK1 LP 26L
Published
2016-12-12
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYEReplacement Heart-ValveCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P870078031

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P870078031HANCOCK PORCINE BIOPROSTHESISMedtronic, Inc.1989-09-28DYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169646544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169646544006431696465446431696465440643169646544

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary 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/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
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
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20
00643169891418Percepta™ Quad CRT-P MRI SureScan™W4TR012017-10-20
00643169891425Serena™ CRT-P MRI SureScan™W1TR022017-10-20
00643169891432Serena™ Quad CRT-P MRI SureScan™W4TR022017-10-20

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
00643169646551Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646568Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169594241HANCOCK® IIMEDTRONIC, INC.DYE2015-10-08
00643169594258HANCOCK® IIMEDTRONIC, INC.DYE2015-10-07
00643169594265HANCOCK® IIMEDTRONIC, INC.DYE2015-10-07