Abiomed, Inc.

Address:22 Cherry Hill Dr,DANVERS,MA,01923,US

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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

Ventricular (Assisst) Bypass (DSQ) (9) Temporary Non-Roller Type Cardiac Support Blood Pump (OZD) (1)

Premarket Exempt

Clear

Impella - 00813502010480 Catalog Number :

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : OZD

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010671 Catalog Number : 0506-0010-HAR

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010688 Catalog Number : 0506-0010-SIL

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010695 Catalog Number : 0506-0032MS-SA

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010701 Catalog Number : 0506-0032M-VA

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010718 Catalog Number : 0506-0042-AR

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010725 Catalog Number : 0506-0042MS-SA

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010732 Catalog Number : 0506-0042M-VA

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010749 Catalog Number : 0506-1032-HA

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

AB5000 - 00813502010756 Catalog Number : 0506-1032-HV

Device Description : Ventricular (Assist) Bypass

Device Class : 3

Duns Number: 050636737

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

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