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

Clip, Implantable (FZP) (4) Stand, Instrument, Ac-Powered, Ophthalmic (HMF) (2) Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (OCL) (2) Device, Surgical, Cryogenic (GXH) (1) Guide, Surgical, Instrument (FZX) (1)

Premarket Exempt

Yes No

Clear

AtriCure System Cart - 00818354010978 Catalog Number : A000507

Device Description : ORLab Touch Screen Pkg

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : HMF

Prescription Use : No

Device Count : 1

Isolator Surgical Ablation System - 00818354011043 Catalog Number : A000602

Device Description : Isolator Synergy Access Surgical Ablation System

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

AtriCure System Cart - 00818354011128 Catalog Number : A000618

Device Description : COMPACT CART 450 INSTALLATION KIT

Device Class : 1

Duns Number: 006133784

Premarket Exempt : Yes

Product Code : HMF

Prescription Use : No

Device Count : 1

Isolator Surgical Ablation System - 00818354011135 Catalog Number : A000625

Device Description : Isolator Long Pen TT, 33 cm long pen

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : OCL

Prescription Use : Yes

Device Count : 1

AtriClip™ LAA Exclusion System - 00818354011173 Catalog Number : A000644

Device Description : AtriClip® Gilinov-Cosgrove LAA Exclusion System 35

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

AtriClip™ LAA Exclusion System - 00818354011203 Catalog Number : A000645

Device Description : AtriClip® Gilinov-Cosgrove LAA Exclusion System 40

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

AtriClip™ LAA Exclusion System - 00818354011234 Catalog Number : A000646

Device Description : AtriClip® Gilinov-Cosgrove LAA Exclusion System 45

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

AtriClip™ LAA Exclusion System - 00818354011265 Catalog Number : A000647

Device Description : AtriClip® Gilinov-Cosgrove LAA Exclusion System 50

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

Isolator Surgical Ablation System - 00818354011326 Catalog Number : A000678

Device Description : Glidepath Tape (3-Unit)

Device Class : 1

Duns Number: 006133784

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

cryoICE Cryoablation System - 00818354011340 Catalog Number : A000683

Device Description : cryoICE CRYO2 10 cm Smooth Aluminum Cryoablation Probe

Device Class : 2

Duns Number: 006133784

Premarket Exempt : No

Product Code : GXH

Prescription Use : Yes

Device Count : 1

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