FDA Registration
Active
🇩🇪 Germany
MAQUET CARDIOPULMONARY GmbH
Reg #: 8010762
·
FEI: 3009649876
·
Expires 2026
Products
9
Proprietary Names
19
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- MAQUET CARDIOPULMONARY GmbH
- Registration Number
- 8010762
- FEI Number
- 3009649876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Neue Rottenburger Strasse 37
- City
- Hechingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K132829
Owner / Operator
- Firm Name
- Maquet Cardiopulmonary GmbH
- Operator Number
- 8010762
- Address
- Kehler Strasse 31
- City
- Rastatt
- State
- Baden-Wurttemberg
- Postal Code
- 76437
- Country
- DE
- Correspondent
- Tom Peters
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2014-01-15 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2014-01-15 |
| Filter, Blood, Cardiopulmonary Bypass, Arterial Line | DTM | Class 2 | Cardiovascular | No | 2014-01-15 |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 1995-05-16 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2007-12-07 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2011-03-19 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2001-09-18 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2012-06-14 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2007-12-10 |
Proprietary Names
QUADROX-iD Diffusion Membrane Oxygenators with Holding Clamp.
HL-20 Integrated Perfusion System
RotaFlow Centrifugal Pump
RotaFlow Centrifugal Pump System
HLS-Set Advanced 7 and 5 (with BIOLINE Coating)
HIT-Set Advanced 7 and 5 (SOFTLINE Coating)
HLS Cannulae, Non Coated, With BIOLINE OR SOFTLINE Coating
Avalon Elite Bi-Caval Dual Lument Catheter
RotaFlow Centrifugal Pump with BIOLINE Coating
QUADROX-iD Adult w and w/o Bioline; QUADROX-i Small Adult with Bioline
Holders, multiple
Sprinter Cart (XL)
CARDIOHELP-i and multiple accessories
Avalon Elite Vascular Access Kit
QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating
Arterial HLS-Cannula, 13 Fr., Non-Coated, With BIOLINE And With SOFTLINE Coating
HLS-Set Advanced 7 and 5 (with BIOLINE Coating);
HIT-Set Advanced 7 and 5 (with SOFTLINE Coating);
HL-20 Twin Pump
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility