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) (3) Cutter, Surgical (FZT) (2) Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (2) Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation (OCM) (1) Stand, Instrument, Ac-Powered, Ophthalmic (HMF) (1) Instrument, Ligature Passing And Knot Tying (HCF) (1) Catheter, Percutaneous (DQY) (1)

Premarket Exempt

No Yes

Clear

Ablation Sensing Unit - 10840143904028 Catalog Number : A000049

Device Description : ASU Footswitch

Device Class : 3

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCM

Prescription Use : Yes

Device Count : 1

AtriCure System Cart - 10840143904035 Catalog Number : A000843

Device Description : CRYO CART KIT ASSEMBLY - TWO TANK SUPPORTS

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : HMF

Prescription Use : No

Device Count : 1

AtriCure Isolator Synergy EnCompass Clamp and Guide System - 10840143904110 Catalog Number : A001143

Device Description : Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide

Device Class :

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

AtriCure Isolator Synergy EnCompass Clamp and Guide System - 10840143904127 Catalog Number : A001144

Device Description : Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide

Device Class :

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

AtriCure Isolator Synergy EnCompass Clamp and GuideSystem - 10840143904134 Catalog Number : A001212

Device Description : Glidepath Magnetic Guide

Device Class :

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

EndoCATH - 10840143904370 Catalog Number : FG-0003-02

Device Description : Large Occlusion Balloon Catheter

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

SureCUT - 10840143904400 Catalog Number : FG-0006-02

Device Description : SureCUT Suture Cutter

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

SofTIP - 10840143904417 Catalog Number : FG-0008-02

Device Description : SofTIP Guide Cannula

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

Lariat RS - 10840143904424 Catalog Number : FG-0028-02

Device Description : Suture Delivery Device

Device Class : 1

Duns Number: 006133784

Premarket Exempt : No

Product Code : GAT, HCF

Prescription Use : Yes

Device Count : 1

TenSURE - 10840143904455 Catalog Number : FG-0017-02

Device Description : TenSURE Suture Tightener

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

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