ABBOTT

ABBOTT

Address:605 Tri-State Parkway,Gurnee,IL,60031,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

CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY (MTD) (6) COMPUTER, DIAGNOSTIC, PROGRAMMABLE (DQK) (4)

Premarket Exempt

No Yes

Clear

FIRMap - 00810591020017 Catalog Number : AR064050

Device Description : FIRMap Catheter 50mm, PACKAGED - Abbott (Global)

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

FIRMap - 00810591020024 Catalog Number : AR064060

Device Description : FIRMap Catheter 60mm, PACKAGED - Abbott (Global)

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

FIRMap - 00810591020031 Catalog Number : AR064070

Device Description : FIRMap Catheter 70mm, PACKAGED - Abbott (Global)

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

FIRMap - 00810591020062 Catalog Number : US-FOC001NS

Device Description : FIRMap Fan Out Cable - US, Non-Sterile

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

FIRMap - 00810591020079 Catalog Number : EXC001NS

Device Description : FIRMap Extension Cable - Global, Non-Sterile

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

FIRMap - 00810591020086 Catalog Number : MAC001NS

Device Description : FIRMap Mapping Adapter Connector

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

RhythmView - 00810591020109 Catalog Number : USB-SSD

Device Description : Assembly, Solid State Drive

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

RhythmView - 00810591020116 Catalog Number : 2000

Device Description : RhythmView Workstation, US

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

RhythmView - 00810591020130 Catalog Number : 2002

Device Description : RhythmView Workstation, US, Streaming

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

RhythmView - 00810591020154 Catalog Number : USB-MEMSTK

Device Description : USB Memory Stick

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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