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

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (OCL) (4) Unit, Cryosurgical, Accessories (GEH) (4) Device, Surgical, Cryogenic (GXH) (2)

Premarket Exempt

No Yes

Clear

AtriCure cryoICE cryoFORM Cryoablation System (CRYOF) - 10840143902505 Catalog Number : A000957

Device Description : cryoICE cryoFORM Corrugated 10cm Cryoablation Probe

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

AtriCure cryoICE cryoSPHERE Cryoablation System - 10840143902543 Catalog Number : A001009

Device Description : CRYOS, Packaged Assembly

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GXH

Prescription Use : Yes

Device Count : 1

AtriCure cryoICE cryoSPHERE Cryoablation System - 10840143902550 Catalog Number : A001012

Device Description : CRYOS-L, Packaged Assembly

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GXH

Prescription Use : Yes

Device Count : 1

Isolator Surgical Ablation System - 10840143902574 Catalog Number : A000318

Device Description : Isolator Linear Pen, 20 mm linear electrode

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

nContact RF Generator - 10840143902796 Catalog Number :

Device Description : Sensing Cable Kit

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : No

Device Count : 1

nContact RF Generator - 10840143902826 Catalog Number :

Device Description : Ground Pad Adapter Cable Kit

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : No

Device Count : 1

cryoICE Cryoablation System - 10840143902925 Catalog Number : A000708

Device Description : ACM Footswitch

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

cryoICE BOX - 10840143902932 Catalog Number : A000727

Device Description : Heaterband

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

cryoICE BOX - 10840143902949 Catalog Number : A000728

Device Description : Heaterband

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

nContact RF Generator - 10840143903083 Catalog Number :

Device Description : Sensing Cable Kit

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : No

Device Count : 1

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