FDA.reportPublic FDA data

Open Pivot™

Primary DI
00613994960252
Brand
Open Pivot™
Company
MEDTRONIC, INC.
Model
500DM27
Device description
MHV 500DM27 STD MITRAL
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
00613994960252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994960252006139949602526139949602520613994960252

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
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
05415067042996Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
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