FDA.reportPublic FDA data

LifeSPARC

Primary DI
00814112020623
Brand
LifeSPARC
Company
CARDIACASSIST, INC.
Model
5900-0001
Device description
Blood pump controller
Published
2020-05-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWAControl, Pump Speed, Cardiopulmonary Bypass
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) UseCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183623000
K211830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183623000LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.2019-07-09KFM
K211830000LifeSPARC SystemCardiacassist, Inc.2022-11-15QNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814112020623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814112020623008141120206238141120206230814112020623

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+14129637770tl.regulatory@livanova.com
18003737421tl.regulatory@livanova.com

Regulatory Flags#

DUNS number
948683941
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814112020166PROTEK Duo5140-46292015-10-10
00814112020319ProtekDuo5140-51312016-09-23
00814112020067TandemHeart5140-62212015-10-10
00814112020098TandemHeart5140-62172015-10-10
00814112020104TandemHeart5130-17175130-17172015-10-10
00814112020111TandemHeart5130-17155130-17152015-10-10
00814112020449ProtekSolo5140-60245140-60242017-01-27
00814112020456ProtekDuo5100-14262017-05-22
00814112020630LifeSPARC5900-00022020-05-27
00814112020692TandemLife LifeSPARC5840-24172020-06-01
00814112020906LifeSPARC5900-00125900-00122022-05-10
00814112020609LifeSPARC5800-10002020-05-29
00814112020685TandemLife LifeSPARC5840-00002020-05-29
00814112020753TandemLung LifeSPARC5830-29162020-05-29
00814112020760TandemLung LifeSPARC5830-31182020-05-29
00814112020777TandemLung LifeSPARC5830-36312020-05-29
00814112020814LifeSPARC5800-10012020-05-29
00814112020562LifeSPARC5900-00002019-12-18
00814112020579LifeSPARC5900-00032019-12-18
00814112020593LifeSPARC5800-00002019-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640135140153CentriMag™Thoratec CorporationDWA2026-02-19
00850000067141Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2025-08-26
07290117830055INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830062INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830093INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830147INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830048INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
17290117830052INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830069INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830086INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
17290117830090INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830109INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830116INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
17290117830144INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
10850007732346VitalFlow Centrifugal Pump MICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-20
10850007732247VitalFlow ConsoleMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732254VitalFlow Motor DriveMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732261VitalFlow Emergency HandcrankMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732278VitalFlow Flow and Bubble Sensor, 2mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732285VitalFlow Power Cord NEMA-5-15, 3mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732292VitalFlow Power Cord CEE 7/7, 2.5mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732308VitalFlow Power Cord 12 V DC, 3mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
00850000067059Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067066Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067073Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067080Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067097Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067103Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067110Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067127Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11