ATRICURE, INC.

Address:3875 Hopyard Rd.,Pleasanton,CA,94588,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

Instruments, Surgical, Cardiovascular (DWS) (8) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1) Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (OCL) (1)

Premarket Exempt

No Yes

Clear

Fusion Ablation System - 00818354012835 Catalog Number :

Device Description : Fusion Magnetic Retriever System

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

Electrosurgical Unit - 00818354013030 Catalog Number :

Device Description : Electrosurgical Unit (115V)

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

LiV™ Instruments - 00818354013139 Catalog Number : N/A

Device Description : LiV Instrument Sterilization Case

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

LiV™ Instruments - 00818354013146 Catalog Number : N/A

Device Description : LiV Atrial Lift System Sterilization Case

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

LiV™ Instruments - 00818354013153 Catalog Number : N/A

Device Description : LiV Mini Blade Holder

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

LiV™ Instruments - 00818354013160 Catalog Number : N/A

Device Description : LiV Suture Catcher

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

LiV™ Instruments - 00818354013177 Catalog Number : N/A

Device Description : LiV Magnetic Probe

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

LiV™ Instruments - 00818354013184 Catalog Number : N/A

Device Description : LiV Vessel Hook, Blunt

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

LiV™ Instruments - 00818354013191 Catalog Number : N/A

Device Description : LiV Nerve Hook

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

LiV™ Instruments - 00818354013207 Catalog Number : N/A

Device Description : LiV Ball Point Probe

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

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