FDA.reportPublic FDA data

HANCOCK® II

Primary DI
00643169594401
Brand
HANCOCK® II
Company
MEDTRONIC, INC.
Model
T510C27
Device description
VLV T510C27 HKII MIT CINCH US PEEK
Published
2015-10-07
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYEReplacement Heart-ValveCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980043048

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980043048HANCOCK II PORCINE BIOPROSTHESISMedtronic, Inc.1999-09-28DYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169594401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169594401006431695944016431695944010643169594401

GMDN Terms#

Term, Definition table
TermDefinition
Mitral 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 mitral 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
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
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

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