CARDIACASSIST, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Control, Pump Speed, Cardiopulmonary Bypass (DWA) (6) Accessory Equipment, Cardiopulmonary Bypass (KRI) (4) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (2) Oxygenator, Cardiopulmonary Bypass (DTZ) (1)

Premarket Exempt

Yes No

Clear

LifeSPARC - 00814112020562 Catalog Number :

Device Description : Blood pump controller, charging station, Power cord, flow sensor, removable batteries

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020579 Catalog Number :

Device Description : Flow Sensor

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020593 Catalog Number :

Device Description : LifeSPARC blood pump kit with accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020609 Catalog Number :

Device Description : LifeSPARC Priming Tray Kit: LIfeSPARC Blood Pump with TandemLung Oxygenator

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DTZ

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020616 Catalog Number :

Device Description : LifeSPARC holster, blood pump securement accessory

Device Class : 1

Duns Number: 948683941

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020623 Catalog Number :

Device Description : Blood pump controller

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020630 Catalog Number :

Device Description : Charging station for blood pump controller

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020647 Catalog Number :

Device Description : Power cord for blood pump controller charging station

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020654 Catalog Number :

Device Description : Removable Batteries of LifeSPARC blood pump controller

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020678 Catalog Number :

Device Description : LifeSPARC holster, blood pump and oxygenator securement accessory

Device Class : 1

Duns Number: 948683941

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 1

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