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

Unit, Cryosurgical, Accessories (GEH) (4) Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation (OCM) (2) Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (OCL) (2) Dissector, Surgical, General & Plastic Surgery (GDI) (1) Guide, Surgical, Instrument (FZX) (1) Lamp, Surgical (FTD) (1)

Premarket Exempt

No Yes

Clear

Cardiac Cryosurgical System - 00818354010008 Catalog Number :

Device Description : 25 mm Flat Cardiac Reusable Probe

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cardiac Cryosurgical System - 00818354010015 Catalog Number :

Device Description : Maze Linear Cardiac Reusable Probe

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cardiac Cryosurgical System - 00818354010022 Catalog Number :

Device Description : 5 mm x 20 mm Angled Cardiac Reusable Probe

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cardiac Cryosurgical System - 00818354010039 Catalog Number :

Device Description : 15 mm Flat Face, Curved, Cardiac Reusable Probe

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Synergy™ Ablation System - 00818354010206 Catalog Number : A000019

Device Description : Ablation and Sensing Unit

Device Class : 3

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCM

Prescription Use : No

Device Count : 1

Synergy™ Ablation System - 00818354010312 Catalog Number : A000049

Device Description : Footswitch ASU2/ASU3

Device Class : 3

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCM

Prescription Use : Yes

Device Count : 1

Isolator Surgical Ablation System - 00818354010343 Catalog Number : A000163

Device Description : Isolator Transpolar Pen

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

Dissector - 00818354010367 Catalog Number : A000195

Device Description : Articulating Dissection Instrument, 27 cm shaft

Device Class : 1

Duns Number: 006133784

Premarket Exempt : No

Product Code : GDI, FTD

Prescription Use : Yes

Device Count : 1

Isolator Surgical Ablation System - 00818354010435 Catalog Number : A000294

Device Description : Glidepath Tape (3-Unit)

Device Class : 1

Duns Number: 006133784

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

Isolator Surgical Ablation System - 00818354010473 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

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