FDA.reportPublic FDA data

Open Pivot™

Primary DI
00613994868367
Brand
Open Pivot™
Company
MEDTRONIC, INC.
Model
502AG27
Device description
AVG 502AG27 CONDUIT
Published
2014-09-23
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
LWQHEART-VALVE, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWQHeart-Valve, MechanicalUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990046000ATS OPEN PIVOT BILEAFLET HEART VALVEMedtronic Ats Medical, Inc.2000-10-13LWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994868367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994868367006139948683676139948683670613994868367

GMDN Terms#

Term, Definition table
TermDefinition
Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graftA sterile artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). The valve component consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about struts attached to the valve housing by hinges; the synthetic polymer blood vessel is designed to conform to the aortic root anatomy and is impregnated with a bioabsorbable animal-derived gelatin.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 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
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
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05415067043078Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043092Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043115Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043191Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043214Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043238Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043351Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043399Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043412Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043436Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043474Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043498Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043511Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043535Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043559Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043573Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043597Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043634Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043771Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043856Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043870Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044174Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044211Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044273Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044297Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044334Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044358Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044952Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067045010Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10