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 Cardiac Ablation Device, For Treatment Of Atrial Fibrillation (OCM) (3) Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (OCL) (3) Guide, Surgical, Instrument (FZX) (2) Dissector, Surgical, General & Plastic Surgery (GDI) (1) Lamp, Surgical (FTD) (1) Stand, Instrument, Ac-Powered, Ophthalmic (HMF) (1)

Premarket Exempt

No Yes

Clear

AtriClip® LAA Exclusion System - 00818354010497 Catalog Number : A000349

Device Description : Selection Guide, AOD1

Device Class : 1

Duns Number: 006133784

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

Synergy™ Ablation System - 00818354010503 Catalog Number : A000362

Device Description : Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve

Device Class : 3

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCM

Prescription Use : Yes

Device Count : 1

Dissector - 00818354010541 Catalog Number : A000418

Device Description : Articulating Dissection Instrument, 18 cm shaft

Device Class : 1

Duns Number: 006133784

Premarket Exempt : No

Product Code : GDI, FTD

Prescription Use : Yes

Device Count : 1

Synergy™ Ablation System - 00818354010558 Catalog Number : A000432

Device Description : Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve

Device Class : 3

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCM

Prescription Use : Yes

Device Count : 1

Synergy™ Ablation System - 00818354010596 Catalog Number : A000435

Device Description : AtriCure Switch Box

Device Class : 3

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCM

Prescription Use : No

Device Count : 1

Synergy™ Ablation System - 00818354010718 Catalog Number : A000437

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 - 00818354010756 Catalog Number : A000452

Device Description : Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

Isolator Surgical Ablation System - 00818354010824 Catalog Number : A000467

Device Description : Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

Isolator Surgical Ablation System - 00818354010893 Catalog Number : A000475

Device Description : Coolrail Linear Pen, 30 mm linear electrode

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

AtriCure System Cart - 00818354010954 Catalog Number : A000503

Device Description : COMPACT CART INSTALLATION KIT

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : HMF

Prescription Use : No

Device Count : 1

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