FDA Registration
Active
🇺🇸 United States
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon
Reg #: 3017540705
·
FEI: 3017540705
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MED MICHIGAN HOLDINGS LLC
- Registration Number
- 3017540705
- FEI Number
- 3017540705
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2140 Oak Industrial Drive NE
- City
- Grand Rapids
- State
- MI
- ZIP
- 49505
- Country
- US
Regulatory Submissions
- 510(k) Number
- K964199
Owner / Operator
- Firm Name
- MED Michigan Holdings LLC
- Operator Number
- 10078584
- Address
- 2140 Oak Industrial Drive NE
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49505
- Country
- US
- Correspondent
- James Wisniewski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2020-10-28 |
Proprietary Names
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Smooth Balloon
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, No Stylet, Textured Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Textured Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Smooth Balloon
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Smooth Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Smooth Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Textured Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Textured Balloon, Stopcock
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility