Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020954746

FEI Number

3020954746

Entity Name

AtriCure, Inc.

City/State/Country

Pleasanton, CA, US

Establishment Address

3875 Hopyard Rd., Suite 160, Pleasanton, CA 94588, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ATRICURE, INC. (Owner Number: 9045049)

Owner / Operator Contact Address

7555 Innovation Way, --, Mason, OH 45040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070126

PMA Number

N/A

All Registered Proprietary Names

LARIAT Suture Delivery Device; SofTIP Guide Cannula TenSURE Suture Tightener EPi-Ease LARIAT RS Suture Delivery Device SureCUT Suture Cutter EndoCATH Occlusion Balloon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2019-11-07
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-11-07
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-11-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-07-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-11-07
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2019-11-07
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-11-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-11-07

Official Correspondent

Janet Hillard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATRICURE, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011788769	AtriCure - Minneapolis	Minnetonka, MN, US
3011706110	ATRICURE, INC.	Mason, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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2953359	Sterigenics U.S. LLC	Hayward, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020954746. Last updated year: 2026. Please use registration number 3020954746 when referencing this establishment in official correspondence.