FDA Registration
Active
🇺🇸 United States
Medtronic, Inc. (Minneapolis, MN 55447)
Reg #: 3008592544
·
FEI: 3008592544
·
Expires 2026
Products
4
Proprietary Names
40
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Medtronic, Inc. (Minneapolis, MN 55447)
- Registration Number
- 3008592544
- FEI Number
- 3008592544
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3800 ANNAPOLIS LANE
- City
- Minneapolis
- State
- MN
- ZIP
- 55447
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121878
- PMA Number
- P990046
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Heart-Valve, Prosthesis | DTJ | Class 1 | Cardiovascular | No | 1992-07-30 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1992-12-02 |
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2010-09-07 |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2013-06-06 |
Proprietary Names
Open Pivot Handle
TriAd Handle
CG Future Handle
Profile 3D Handle
Enable Folding System
Open Pivot Rotator
Duran Ancore Handle
Open Pivot Holder
HEART-VALVE
Contour 3D Handle
Simulus Handle
Threaded or Valve handle
Avalus Valve Handle
PROSTHESIS HOLDER
MITRAL COLLAR AND TIE
Actuators
Rotation Tool Kit
AORTIC CUFF
Universal Mounting Rail
pinch on tool
MEDIUM BLADE SET TOOL
Lead Accessory Kit
Adjustable Slitter
Implant Tool Kit
ATRIAL LIFT SYSTEM
Accessory Port ATS Medical Thoracic Port System
EXTRA LG BLADE SET TOOL
INTERCOSTAL RETRACTOR SYSTEM
SUTURE BELT
LARGE BLADE SET TOOL
STERILIZATION TRAY TOOL
RETRACTOR RACK TOOL
SMALL BLADE SET TOOL
Mounting Rail
Universal II Slitter
MHV ATS Open Pivot Aortic Valved Graft
ATS Open Pivot Bi-leaflet
Cryoflex
CLAMP CRYOFLEX
Cardioblate CryoFlex Surgical Ablation System Probes
Establishment Types
Manufacture Medical Device