FDA.reportPublic FDA data

HVAD® Pump Surgical Tools

Primary DI
00888707005388
Brand
HVAD® Pump Surgical Tools
Company
Heartware Inc.
Model
MCS1718ST
Catalog number
MCS1718ST
Published
2020-12-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
P100047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100047000HEARTWARE VENTRICULAR ASSIST SYSTEMMedtronic2012-11-20DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888707005388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888707005388008887070053888887070053880888707005388

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.

Regulatory Flags#

DUNS number
146054536
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888707008204HVAD® Pump Surgical Tools131813182020-11-10
00888707008723HVAD® Pump Surgical Tools – Extended Length132813282020-11-10
00763000989514HVAD™ ControllerMCS1421CN2025-08-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000923686HeartWare™ Shoulder PackHeartware, Inc.DSQ2026-05-31
00763000923655HeartWare™ BatteryHeartware, Inc.DSQ2026-05-01
07640135140153CentriMag™Thoratec CorporationDSQ2026-02-19
00763000989514HVAD™ ControllerHeartware Inc.DSQ2025-08-30
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