Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2242352

FEI Number

2242352

Entity Name

Maquet Cardiovascular LLC

City/State/Country

Wayne, NJ, US

Establishment Address

45 BARBOUR POND DRIVE, Wayne, NJ 07470, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Maquet Cardiovascular LLC (Owner Number: 10024202)

Owner / Operator Contact Address

45 Barbour Pond Drive, Wayne, NJ 07470, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MULTIPLE-VASOVIEW Vasoview Accessory Pack VASOSHIELD Pressure Controlling Syringe Vessel Harvesting System VasoView 6 Pro Endoscopic Vasoview Hemopro 3 Power Supply Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield Heartstring III Axius Coronary Shunt Fusion Bioline Vascular Graft VASOVIEW DISSECTION CANNULA STERILIZATION TRAY SHORT PORT BTT 7MM ENDOSCOPE Vasoview Accessory Pack 5MM ENDOSCOPE AXIUS XPOSE DEVICE ACROBAT-i Vaccum Positioner System Acrobat-i Vacuum Stabilizer System Acrobat SUV Vacuum Off-Pump System XPOSE Device VASOVIEW HEMOPRO2 Vasoview Hemopro 2 with Vasoshield Axius Blower/Mister Ultima Activator II Drive Mechanism ACCESSRAIL Platform (Deep Blade) ACCESSRAIL Platform (Standard Blade) MIDCAB STABILIZER SYSTEM MIDCAB STABILIZATION SYSTEM Mira-i CS Retractor System Heartstring Aortic Cutter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-01-10
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2009-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-11-30
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2009-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-06-09
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-12-21
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2008-03-06
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2026-05-20
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Cardiovascular	Class 2	870.3450	2026-05-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-10
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2008-01-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-03-11
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-03-27
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2008-01-10
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-11-30

Official Correspondent

Donna Marshall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Maquet Cardiovascular LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1640201	Intervascular SAS	LA CIOTAT Bouches-du-Rhone, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2014	Maquet Cardiovascular, LLC	1	Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0036-2026	W L Gore & Associates, Inc.	2	GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2242352. Last updated year: 2026. Please use registration number 2242352 when referencing this establishment in official correspondence.