FDA Registration
Active
🇺🇸 United States
Maquet Cardiovascular LLC
Reg #: 2242352
·
FEI: 2242352
·
Expires 2026
Products
10
Proprietary Names
38
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- Maquet Cardiovascular LLC
- Registration Number
- 2242352
- FEI Number
- 2242352
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 45 BARBOUR POND DRIVE
- City
- Wayne
- State
- NJ
- ZIP
- 07470
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041981
Owner / Operator
- Firm Name
- Maquet Cardiovascular LLC
- Operator Number
- 10024202
- Address
- 45 Barbour Pond Drive
- City
- Wayne
- State
- NJ
- Postal Code
- 07470
- Country
- US
- Correspondent
- Donna Marshall
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2008-01-10 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2009-11-30 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2024-12-21 |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | Class 2 | Cardiovascular | No | 2026-05-20 |
| Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | DYF | Class 2 | Cardiovascular | No | 2026-05-20 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2008-01-10 |
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2008-01-10 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2026-03-27 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2008-01-10 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2009-11-30 |
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
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
Vasoview Dissection Cannula
Blunt Tip Trocar Port
Vasoview Hemopro 2 Extension Cable
Bipolar Extension Cable
Vasoview Hemopro Extension Cable
Fixed Distance Active Return Cord
7mm Extended Length Endoscope
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility