FDA.reportPublic FDA data

HVAD™ Controller

Primary DI
00763000989514
Brand
HVAD™ Controller
Company
Heartware Inc.
Model
MCS1421CN
Device description
CONTROLLER MCS1421CN WW
Published
2025-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSQVentricular (assist) bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSQVentricular (Assist) BypassUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100047226

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100047226HEARTWARE VENTRICULAR ASSIST SYSTEMMedtronic2012-11-20DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000989514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000989514007630009895147630009895140763000989514

GMDN Terms#

Term, Definition table
TermDefinition
Implantable ventricular circulatory assist systemA portable assembly of devices intended to provide mechanical assistance to a heart ventricle(s), typically by pumping blood from the left ventricle to the aorta through an extra-cardiac circuit. It includes an implantable pump(s), connecting cannula/graft(s), a percutaneous lead, and external components (e.g., battery pack, controller). It is typically intended to be used as a bridge to heart transplantation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-20 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
146054536
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888707006880HeartWare® Controller DC Adapter144014402020-06-29
00888707000376HeartWare® Battery165016502015-06-24
00888707006859HVAD® Controller1403US1403US2019-10-07
00888707006866HeartWare® Controller AC Adapter1430US1430US2019-10-07
00888707006873HeartWare® Battery1650DE1650DE2019-10-07
00888707007641HVAD® Pump Outflow Graft112511252020-11-10
00888707008020Alarm Adapter145014502020-11-10
00888707008051Data Cable157515752020-11-10
00888707008778HeartWare® Battery1650DE1650DE2020-11-10
00888707009942HeartWare® Battery1650DE1650DE2022-08-15
00888707009041HVAD® Pump Implant KitMCS1705PUMCS1705PU2021-03-01
00888707005364HVAD® Pump Implant KitMCS1705PUMCS1705PU2020-12-14
00888707005371HVAD® Pump Implant AccessoriesMCS1753AKMCS1753AK2020-12-14
00888707007634HVAD® Pump Outflow GraftMCS1725OGMCS1725OG2020-12-14
00888707006897HeartWare® Battery1650DE1650DE2020-06-29
00888707000017HVAD® Pump Implant Kit (Enhanced)110311032014-08-13
00888707000024Driveline Extension Cable100US100US2014-08-13
00888707000062HVAD Pump Implant Kit110311032014-10-01
00888707000079HeartWare® Battery165016502014-08-13
00888707000086HeartWare® Monitor AC Adapter1555US1555US2014-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000923655HeartWare™ BatteryHeartware, Inc.DSQ2026-05-01
07640135140153CentriMag™Thoratec CorporationDSQ2026-02-19
05415067039385HeartMate 3™Thoratec CorporationDSQ2025-07-21
05415067039545HeartMate™Thoratec CorporationDSQ2025-07-21
05415067038784HeartMate 3™Thoratec CorporationDSQ2025-07-21
05415067039446HeartMate 3™Thoratec CorporationDSQ2025-07-21
05415067039880HeartMate™Thoratec CorporationDSQ2025-07-21
05415067039903HeartMate™ GoGear™Thoratec CorporationDSQ2025-07-21
05415067039422HeartMate 3™Thoratec CorporationDSQ2025-07-16
05415067037800HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038821HeartMate 3™Thoratec CorporationDSQ2025-05-16
05415067039606HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039644HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039781HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039842HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039866HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039927HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
15415067037807HeartMate™Thoratec CorporationDSQ2025-05-16
05415067037824HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038173HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067038609HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038746HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039040HeartMate™Thoratec CorporationDSQ2025-05-16
15415067039641HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039804HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039828HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067038456HeartMate 3™Thoratec CorporationDSQ2025-04-07
05415067039323HeartMate 3™Thoratec CorporationDSQ2025-04-02
05415067038296HeartMate™Thoratec CorporationDSQ2025-04-02
05415067038234HeartMate™Thoratec CorporationDSQ2024-03-22